Adjustable annuloplasty devices and adjustment mechanisms therefor

ABSTRACT

A method is provided, including, delivering into a heart of a patient an annuloplasty ring structure including a body portion and an adjusting mechanism configured to adjust a size of the body portion of the annuloplasty ring structure, the adjusting mechanism including a housing, and following the delivering, moving the housing with respect to the body portion. Other applications are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/141,606 which published as 2012/0136436 and which is a USnational phase of PCT Patent Application PCT/IL2009/001209, whichpublished as WO 2010/073246, and which:

(a) is a continuation-in-part of and claims the priority from U.S.patent application Ser. No. 12/341,960 to Cabiri, entitled, “Adjustablepartial annuloplasty ring and mechanism therefor,” filed Dec. 22, 2008,which issued as U.S. Pat. No. 8,241,351;

(b) is a continuation-in-part of and claims the priority from U.S.patent application Ser. No. 12/435,291 to Maisano et al., entitled,“Adjustable repair chords and spool mechanism therefor,” filed on May 4,2009, which issued as U.S. Pat. No. 8,147,542;

(c) claims the priority from U.S. Provisional Patent Application61/283,445 to Sheps et al., entitled, “Delivery tool for rotation ofspool and adjustment of annuloplasty device,” filed Dec. 2, 2009; and

(d) is related to:

-   -   (1) PCT Publication WO 06/097931 to Gross et al., entitled,        “Mitral Valve treatment techniques,” filed Mar. 15, 2006;    -   (2) U.S. patent application Ser. No. 12/548,991 to Maisano et        al., entitled, “Implantation of repair chords in the heart,”        filed on Aug. 27, 2009, which issued as U.S. Pat. No. 8,808,368;        and    -   (3) U.S. Provisional Patent Application 61/265,936 to Miller et        al., entitled, “Delivery tool for implantation of spool assembly        coupled to a helical anchor,” filed on Dec. 2, 2009.

All of these applications are incorporated herein by reference.

FILED OF THE INVENTION

Some applications of the present invention relate in general to valverepair. More specifically, some applications of the present inventionrelate to repair of a mitral valve of a patient.

BACKGROUND

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

U.S. Pat. No. 7,431,692 to Zollinger et al. describes an adjustablesupport pad for adjustably holding a tensioning line used to applytension to a body organ. The adjustable support pad can include alocking mechanism for preventing slidable movement of the tensioningelement in one or both directions. The locking mechanism may includespring-loaded locks, rotatable cam-like structures, and/or rotatablespool structures. The adjustable support pad may be formed from rigid,semi-rigid, and/or flexible materials, and may be formed to conform tothe outer surface of a body organ. The adjustable support pad can beconfigured to adjustably hold one or more separate tensioning lines, andto provide for independent adjustment of one or more tensioning lines orgroups thereof.

US Patent Application Publication 2007/0016287 to Cartledge et al.describes an implantable device for controlling shape and/or size of ananatomical structure or lumen. The implantable device has an adjustablemember configured to adjust the dimensions of the implantable device.The implantable device is housed in a catheter and insertable from aminimally invasive surgical entry. An adjustment tool actuates theadjustable member and provide for adjustment before, during or after theanatomical structure or lumen resumes near normal to normal physiologicfunction.

US Patent Application Publication 2004/0236419 to Milo describes methodsfor reconfiguring an atrioventricular heart valve that may use systemscomprising a partial or complete annuloplasty rings proportioned toreconfigure a heart valve that has become in some way incompetent, apair of trigonal sutures or implantable anchors, and a plurality ofstaples which may have pairs of legs that are sized and shaped forassociation with the ring at spaced locations along its length. Thesesystems permit relative axial movement between the staples and the ring,whereby a patient's heart valve can be reconfigured in a manner thatdoes not deter subtle shifting of the native valve components.Shape-memory alloy material staples may have legs with free ends thatinterlock following implantation. Annuloplasty rings may be complete orpartial and may be fenestrated. One alternative method routes a flexiblewire, preferably of shape-memory material, through the bights ofpre-implanted staples. Other alternative systems use linkers ofshape-memory material having hooked ends to interengage with staples orother implanted supports which, following implantation, decrease ineffective length and pull the staples or other supports toward oneanother so as to create desired curvature of the reconfigured valve.These linkers may be separate from the supports or may be integral withthem and may have a variety of shapes and forms. Various ones of thesesystems are described as being implanted non-invasively using a deliverycatheter.

US Patent Application Publication 2005/0171601 to Cosgrove et al.describes an annuloplasty repair segment and template for heart valveannulus repair. The elongate flexible template may form a distal part ofa holder that also has a proximal handle. Alternatively, the templatemay be releasably attached to a mandrel that slides within a deliverysheath, the template being released from the end of the sheath to enablemanipulation by a surgeon. A tether connecting the template and mandrelmay also be provided. The template may be elastic, temperatureresponsive, or multiple linked segments. The template may be alignedwith the handle and form a two- or three-dimensional curve out ofalignment with the handle such that the annuloplasty repair segmentattached thereto conforms to the curve. The template may be actively orpassively converted between its straight and curved positions. Thecombined holder and ring is especially suited for minimally-invasivesurgeries in which the combination is delivered to an implantation sitethrough a small access incision with or without a cannula, or through acatheter passed though the patient's vasculature.

The following patents and patent application publications, relevantportions of which are incorporated herein by reference, may be ofinterest:

PCT Patent Application Publication WO 07/136783 to Cartledge et al.

U.S. Pat. No. 5,306,296 to Wright et al.

U.S. Pat. No. 6,569,198 to Wilson et al.

U.S. Pat. No. 6,619,291 to Hlavka et al.

U.S. Pat. No. 6,626,930 to Allen et al.

U.S. Pat. No. 6,629,534 to St. Goar et al.

U.S. Pat. No. 6,752,813 to Goldfarb et al.

U.S. Pat. No. 6,764,510 to Vidlund et al.

U.S. Pat. No. 7,004,176 to Lau

U.S. Pat. No. 7,101,395 to Tremulis et al.

U.S. Pat. No. 7,175,660 to Cartledge et al.

US Patent Application Publication 2003/0050693 to Quijano et al

US Patent Application Publication 2003/0105519 to Fasol et al.

US Patent Application Publication 2003/0167062 to Gambale et al.

US Patent Application Publication 2004/0024451 to Johnson et al.

US Patent Application Publication 2004/0122514 to Fogarty et al.

US Patent Application Publication 2004/0148021 to Cartledge et al.

US Patent Application Publication 2004/0236419 to Milo

US Patent Application Publication 2005/0171601 to Cosgrove et al.

US Patent Application Publication 2005/0216039 to Lederman

US Patent Application Publication 2005/0288781 to Moaddeb et al.

US Patent Application Publication 2007/0080188 to Spence et al.

US Patent Application Publication 2007/0118151 to Davidson

US Patent Application Publication 2007/0162111 to Fukamachi et al.

US Patent Application Publication 2009/0177266 to Powell et al.

US Patent Application Publication 2007/0255400 to Parravicini et al.

US Patent Application Publication 2008/0004697 to Lichtenstein et al.

The following articles, which are incorporated herein by reference, maybe of interest:

O'Reilly S et al., “Heart valve surgery pushes the envelope,” MedtechInsight 8(3): 73, 99-108 (2006)

Dieter R S, “Percutaneous valve repair: Update on mitral regurgitationand endovascular approaches to the mitral valve,” Applications inImaging, Cardiac Interventions, Supported by an educational grant fromAmersham Health pp. 11-14 (2003)

Swain C P et al., “An endoscopically deliverable tissue-transfixingdevice for securing biosensors in the gastrointestinal tract,”Gastrointestinal Endoscopy 40(6): 730-734 (1994)

Odell J A et al., “Early Results of a Simplified Method of Mitral ValveAnnuloplasty,” Circulation 92:150-154 (1995)

SUMMARY OF EMBODIMENTS

In some applications of the present invention, apparatus is providedcomprising an adjustable annuloplasty structure configured to repair adilated mitral valve of a patient. At least a portion of theannuloplasty structure comprises a flexible, longitudinally-compressiblesegment (e.g., coiled structures, stent-like struts, or a braided mesh).The annuloplasty structure is shaped to define a lumen thereof thathouses a flexible member, e.g., a contracting wire. The annuloplastystructure comprises a contracting mechanism which facilitatescontracting of the annuloplasty structure. The contracting mechanismcomprises a spool to which a first end of the flexible member iscoupled. Typically, a second end of the flexible member is not coupledto the spool, but rather is coupled to a portion of the annuloplastystructure.

In some applications of the present invention, the annuloplastystructure is shaped to provide an adjustable partial annuloplastystructure. In these applications, the annuloplasty structure comprisesan elongate structure which is coupled at a first end thereof to thecontracting mechanism. The first end of the flexible member is coupledto the spool while the second end of the flexible member is coupled to asecond end of the elongate structure.

Typically, during a resting state thereof, the elongate structureassumes a linear configuration. The elongate structure is made to assumea curved configuration in which the elongate structure provides apartial annuloplasty ring. In some applications of the presentinvention, the first and second ends of the elongate structure arecoupled together such that the elongate structure forms an annuloplastyring. For example, the first and second ends of the elongate element areeach coupled to a housing surrounding the contracting mechanism. Ineither application of the present invention, the annuloplasty structureis contracted by the contracting mechanism such that the dimensions ofthe annuloplasty structure are reduced and the structure contractsradially, thereby contracting the annulus.

As the operating physician rotates the spool of the contractingmechanism, a portion of the flexible member is wound around the spool.In response to continued rotation of the spool, increasing portions ofthe flexible member are wrapped around the spool, which causes theflexible member to pull on the second end of the elongate structuretoward the contracting mechanism. Responsively, the compressible elementis compressed between the first and second ends of the elongatestructure. Thus, the flexible member helps regulate a spatialconfiguration of the annuloplasty structure.

In some applications of the present invention, during a resting state,the annuloplasty structure defines a linear shape. Subsequently, duringimplantation, the annuloplasty structure is made to assume at least partof a ring-shaped structure. The annuloplasty structure may be advancedtoward the annulus of a valve in any suitable procedure, e.g.,transcatheter, minimally invasive, or in an open heart procedure.

In some applications of the present invention, a delivery tool isprovided for reversible coupling of a rotatable adjusting mechanismthereto, delivery of the adjusting mechanism to tissue of a patient, androtation of a rotatable structure of the adjusting mechanism. Typically,the delivery tool facilitates implantation of the adjusting mechanism incardiac tissue of the patient. Typically, the adjusting mechanism iscoupled to an implant, e.g., an annuloplasty device, and facilitatescontraction and expansion of the implant. For such applications in whichthe implant comprises an annuloplasty device, this contraction andexpansion of the annuloplasty device facilitates, in turn, contractionand expansion of the annulus of an atrioventricular valve of thepatient.

The rotatable structure of the adjusting mechanism is shaped to defineproximal and distal openings and a channel extending between theproximal and distal openings. A proximal portion of an inner wall of therotatable structure that surrounds the channel is shaped to define athreaded portion, e.g., a tapered threaded portion that decreases indiameter from the proximal opening.

The delivery tool has a distal end which is reversibly couplable to theadjusting mechanism and comprises a manipulator, e.g., a screwdrivertool. The manipulator is shaped to define a threaded portion that screwsinto the threaded portion of the rotatable structure. The delivery toolcomprises an ergonomic proximal handle portion that comprises at leasttwo separate rotating members which control separate functions of themanipulator at the distal end of the tool. A proximal-most first knobrotates the manipulator sufficiently to couple together the respectivethreaded portions of the manipulator and the rotatable structure. Asecond knob that is distal to the proximal-most knob facilitatesrotation of the manipulator sufficiently to rotate the rotatablestructure following the coupling of the manipulator to the rotatablestructure. The second knob is coupled to a visual indicator whichindicates the number of rotations of the screwdriver, and thereby, thenumber of rotations of the rotatable structure. Rotating the second knobin a first direction rotates the second knob such that it advancesdistally along a helical rotation path. The distal end of the helicalrotation path restricts rotation of the second knob and therebyrestricts rotation of the rotatable structure beyond a predeterminedamount.

The rotatable structure is coupled to a locking mechanism whichrestricts rotation of the rotatable structure in a resting state of thelocking mechanism. The delivery tool comprises an elongate lockingmechanism release rod which is slidable within a lumen of the deliverytool in order to release the locking mechanism from the rotatablestructure prior to the rotating of the rotatable structure responsivelyto the rotation of the second knob.

There is therefore provided, in accordance with some applications of thepresent invention, apparatus configured to be implanted in a body of asubject, including:

an implant structure having first and second portions thereof;

a rotatable structure coupled to the implant structure in a vicinity ofthe first portion thereof; and

a flexible member having a first portion and at least one end portionthereof, at least the first portion being disposed in contact with therotatable structure, and the at least one end portion of the flexiblemember being not disposed in contact with the rotatable structure,

and, in response to rotation of the rotatable structure in a firstdirection thereof, successive portions of the flexible member contactthe rotatable structure to pull the at least one end portion of theflexible member toward the first portion of the implant structure, andresponsively to draw the first and second portions of the implantstructure toward each other.

In some applications of the present invention, the rotatable structureincludes a spool,

the flexible member includes a longitudinal member selected from thegroup consisting of: a wire, a thread, a cable, and a rope, and

in response to rotation of the spool in a first direction, successiveportions of the longitudinal member wind around the spool.

In some applications of the present invention, the rotatable structureincludes a rotatable structure having a plurality of teeth, the flexiblemember includes a longitudinal member selected from the group consistingof: a band and a ribbon,

the flexible member is shaped so as to define a plurality of engagingelements, and

in response to rotation of the rotatable structure, the plurality ofteeth matingly engage the plurality of engaging elements.

In some applications of the present invention, the first and secondportions of the implant structure include first and second end portions,

the first portion of the flexible member is disposed at the first endportion of the implant structure, and

the at least one end portion of the flexible member is disposed at thesecond end portion of the implant structure.

In some applications of the present invention, the flexible memberincludes first and second end portions,

the at least one end portion of the flexible member defines at least oneend selected from the group consisting of: the first end portion and thesecond end portion of the flexible member; and

the flexible member defines the first portion thereof in a vicinity ofthe flexible member that is between the first and second end portionsthereof.

In some applications of the present invention, the implant structureincludes first and second end portions, and the implant structuredefines the first portion thereof in a vicinity of the implant structurethat is between the first and second end portions thereof.

In some applications of the present invention, the flexible memberincludes first and second end portions,

the flexible member defines the first portion thereof in a vicinity ofthe flexible member that is between the first and second end portionsthereof,

the first end portion of the flexible member is coupled to the first endportion of the implant structure, and

the second end portion of the flexible member is coupled to the secondend portion of the implant structure.

In some applications of the present invention, the flexible memberdefines a first flexible member including first and second end portionsand the first portion, and the first portion of the first flexiblemember defines the first end portion thereof, and

the first end portion of the first flexible member is coupled to therotatable structure.

In some applications of the present invention, the apparatus includes asecond flexible member including first and second end portions thereof,and

the first end portion of the second flexible member is coupled to therotatable structure, and

the second end portion of the flexible member is coupled to the secondend portion of the implant structure.

There is additionally provided, in accordance with some applications ofthe present invention, a method for adjusting a dimension of an implantstructure having first and second portions, including:

rotating in a first direction a rotatable structure coupled to the firstportion of the implant structure;

by the rotating, contacting with the rotatable structure successiveportions of a flexible member;

by the rotating, pulling an end portion of the flexible member towardthe first portion of the implant structure; and

responsively to the pulling, drawing the first and second portions ofthe implant structure toward each other.

There is further provided, in accordance with some applications of thepresent invention, apparatus configured to be implanted in a body of asubject, including:

an implant structure having first and second portions thereof;

a spool coupled to the implant structure in a vicinity of the firstportion thereof; and

a flexible member coupled at a first end thereof to the spool, and notattached at a second end thereof to the spool, the flexible member:

-   -   in response to rotation of the spool in a first direction        thereof, configured to be wound around the spool, and,        responsively, to pull the second end of the flexible member        toward the first portion of the implant structure, and        responsively to draw the first and second portions of the        implant structure toward each other.

In some applications of the present invention, the flexible member isconfigured to be unwound from around the spool and to facilitateexpansion of the implant structure in response to rotation of the spoolin a second direction thereof that is opposite the first direction.

In some applications of the present invention, the implant structureincludes expanded polytetrafluoroethylene (ePTFE).

In some applications of the present invention, the implant structure iscoated with polytetrafluoroethylene.

In some applications of the present invention, the implant structure isconfigured to be implanted along an annulus of a mitral valve of thesubject,

the flexible member is configured to contract the implant structure inresponse to the rotation of the spool in the first direction, and

the implant structure is configured to contract the annulus in responseto the contraction thereof.

In some applications of the present invention, the second portion of theimplant structure is coupled to the spool in a manner that causes theimplant structure to be shaped to define an annuloplasty ring.

In some applications of the present invention, the apparatus isconfigured to be implanted along an annulus of a mitral valve of thesubject, and the apparatus is configured to be transcatheterallyadvanced toward the annulus.

In some applications of the present invention, the apparatus includes alocking mechanism coupled to the implant structure and configured torestrict rotation of the spool.

In some applications of the present invention, the first and secondportions are disposed adjacently to first and second ends of the implantstructure, respectively,

the apparatus is configured to be implanted along an annulus of a mitralvalve of the subject in a manner in which the first end of the structureis distanced from the second end of the structure, and

the implant structure in its implanted state defines a partialannuloplasty ring.

In some applications of the present invention, the apparatus isconfigured to be implanted along an annulus of a mitral valve of thesubject,

the first portion of the implant structure is configured to be coupledto a first location along the annulus in a vicinity of a first trigoneadjacent to the mitral valve, and

the second portion of the implant structure is configured to be coupledto a second location along the annulus in a vicinity of a second trigoneadjacent to the mitral valve.

In some applications of the present invention, the implant structure isshaped to provide first and second ends in communication with the firstand second portions, respectively,

the first end is configured to be coupled to the first location alongthe annulus in the vicinity of the first trigone adjacent to the mitralvalve, and

the second end of the implant structure is configured to be coupled tothe second location along the annulus in the vicinity of the secondtrigone adjacent to the mitral valve.

In some applications of the present invention, the first portion hasfirst and second ends, the first end of the first portion being coupledto the spool,

the second portion has first and second ends, the first end of thesecond portion being coupled to the spool,

the apparatus includes first and second flexible members each havingfirst and second ends,

the first end of the first flexible member is coupled to the spool, andthe second end of the first flexible member is coupled to the second endof the first portion, and

the first end of the second flexible member is coupled to the spool, andthe second end of the second flexible member is coupled to the secondend of the first portion.

In some applications of the present invention, in response to rotationof the spool in a first direction thereof, respective portions of thefirst and second flexible members are configured to be wound around thespool, and, responsively, to pull the respective second ends of thefirst and second flexible members toward the spool, and responsively todraw the first and second portions of the implant structure toward eachother.

In some applications of the present invention, the apparatus isconfigured to be implanted along an annulus of a mitral valve of a heartof the subject,

a first section of the implant structure is flexible and longitudinallycompressible, and

a second section in series with the first section of the implantstructure, the second section being flexible and less longitudinallycompressible than the first section.

In some applications of the present invention, the second section is notlongitudinally compressible.

In some applications of the present invention, a radius of curvature ata center of the first section is smaller than a radius of curvature at acenter of the second section, when no external force is applied to theimplant structure.

In some applications of the present invention, the second section of theimplant structure has first and second ends thereof and a body portiondisposed between the first and second ends, the second section of theimplant structure being configured to be disposed along a portion of theannulus in a manner in which:

the first end of the second section is configured to be coupled to theannulus in a vicinity of a left trigone of the heart that is adjacent toa mitral valve of the subject,

the second end of the second section is configured to be coupled to theannulus in a vicinity of a right trigone of the heart that is adjacentto the mitral valve, and

the body portion is configured to be disposed along the annulus in avicinity of the annulus that is between the left and right trigones.

In some applications of the present invention, the body portion disposedbetween the first and second ends of the second section of the implantstructure has a length of 10-50 mm.

In some applications of the present invention, in the apparatus isconfigured to be implanted along an annulus of a mitral valve of thesubject in a manner in which the implant structure is formed into atleast a portion of an annuloplasty ring.

In some applications of the present invention, the apparatus includes aplurality of sutures, each suture of the plurality of sutures beingconfigured to be fastened to a respective location along a circumferenceof the annulus of the subject, the plurality of sutures being configuredto facilitate advancement of the implant structure toward the annulus.

In some applications of the present invention, the plurality of suturesare configured to be coupled to the implant structure at respectivelocations thereof that are in parallel with the respective locationsalong the circumference of the annulus of the subject, and the implantstructure is formed into the annuloplasty ring in response to thecoupling.

In some applications of the present invention, the implant structure iscompressible along a longitudinal axis of the implant structure.

In some applications of the present invention, the implant structureincludes a coiled structure having a lumen thereof.

In some applications of the present invention, the flexible member isdisposed within the lumen of the coiled structure.

In some applications of the present invention, in response to rotationof the spool, the flexible member is configured to longitudinallycompress the implant structure.

In some applications of the present invention, the apparatus includes aplurality of sutures configured to be coupled to an annulus of a mitralvalve of the subject and to facilitate implantation of the implantstructure along the annulus.

In some applications of the present invention, the apparatus includes aplurality of anchors respectively coupled to the plurality of suturesand configured to be anchored to tissue of the annulus of the subject.

In some applications of the present invention, the plurality of anchorsare configured to lock the implant structure in place with respect tothe annulus.

In some applications of the present invention, the plurality of anchorsare configured to be implanted along a circumference of the annulus, andto be coupled to the implant structure in a manner which forms theimplant structure into a curved configuration.

In some applications of the present invention, the spool has a first endshaped to define a first opening, and a second end shaped to define asecond opening, the spool being shaped to define a channel extendingfrom the first opening to the second opening, the channel beingconfigured for passage therethrough of an elongate tool, and

the second end of the spool has a lower surface thereof shaped to:

-   -   provide at least a portion thereof having a circumference, and    -   define one or more recesses at locations along the        circumference.

In some applications of the present invention, the apparatus includes amechanical element having a planar surface coupled to the lower surfaceof the spool, the mechanical element being shaped to provide:

-   -   a protrusion protruding out of a plane of the planar surface of        the mechanical element, the protrusion being disposed within one        of the recesses during a resting state of the mechanical        element, in a manner that restricts rotation of the spool, and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to dislodge the protrusion        from within the recess in response to a force applied thereto by        the elongate tool.

In some applications of the present invention, the spool has a first endand a second end, the first end being shaped to receive a portion of atool, and

the first end of the spool has an upper surface thereof shaped to:

-   -   provide at least a portion thereof having a circumference, and    -   define one or more recesses at respective locations along the        circumference.

In some applications of the present invention, the apparatus includes:

a mechanical element having a planar surface coupled to the uppersurface of the spool, the mechanical element being shaped to provide atleast one protrusion protruding out of a plane of the planar surface ofthe mechanical element, the protrusion being disposed within one of therecesses during a resting state of the mechanical element, in a mannerthat restricts rotation of the spool; and

a compressible element coupled to the second end of the spool, thecompressible element being configured to be compressed and facilitatedislodging of the protrusion from within the recess in response to aforce applied to the spool by the elongate tool.

There is also provided, in accordance with some applications of thepresent invention, apparatus for adjusting at least one dimension of animplant, including:

a rotatable structure having a first end shaped to define a firstopening, and a second end shaped to define a second opening, therotatable structure being shaped to define a channel extending from thefirst opening to the second opening, the channel being configured forpassage therethrough of an elongate tool, and the second end of thestructure having a lower surface thereof shaped to define one or morerecesses; and

a mechanical element having a surface coupled to the lower surface ofthe rotatable structure, the mechanical element being shaped to provide:

-   -   a protrusion protruding out of a plane of the surface of the        mechanical element, the protrusion being disposed within one of        the recesses during a resting state of the mechanical element,        in a manner that restricts rotation of the rotatable structure,        and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to dislodge the protrusion        from within the recess in response to a force applied thereto by        the elongate tool.

In some applications of the present invention, the lower surface isshaped to provide at least a portion thereof having a circumference, andthe one or more recesses are disposed along the circumference.

In some applications of the present invention, during a first period:

-   -   the elongate tool is configured to maintain the protrusion in a        position in which it is dislodged from the recess, and    -   the elongate tool is configured to rotate the rotatable        structure, and during a second period:    -   the elongate tool is configured to remove the elongate tool from        the channel and to position the protrusion in the recess, and    -   the rotatable structure is restricted from being rotated.

In some applications of the present invention, during the first period,the rotatable structure is rotatable in first and second directions, thefirst direction being opposite the second direction.

In some applications of the present invention, the apparatus includes ahousing surrounding the rotatable structure, the housing being coupledin part to a cap having a surface that is disposed in parallel with thelower surface of the rotatable structure, and the depressible portion isdisposed between the lower surface of the rotatable structure and thecap, and the cap is shaped to define a recessed portion thereofconfigured to receive the depressible portion during a depressed stateof the depressible portion.

In some applications of the present invention, the apparatus includes ahousing surrounding the rotatable structure, the housing being shaped todefine a recessed portion thereof configured to receive the protrusionduring the resting state of the mechanical element.

In some applications of the present invention the apparatus includes, aflexible, longitudinal member having first and second end portionsthereof, and at least the first end portion of the longitudinal memberis coupled to the rotatable structure in a manner in which, as a resultof rotation of the rotatable structure:

the first end portion of the longitudinal member advances with respectto the rotatable structure, and

a configuration of the longitudinal member changes.

In some applications of the present invention, in the first end portionof the longitudinal member is reversibly coupled to the rotatablestructure.

In some applications of the present invention, the apparatus includes anannuloplasty device having at least one end portion,

the annuloplasty device defines the implant, the rotatable structure iscoupled to the annuloplasty device;

the longitudinal member is coupled at the second end portion thereof tothe at least one end portion of the annuloplasty device, and

the rotatable structure is rotatable to advance the first end portion ofthe longitudinal member with respect to the rotatable structure in amanner which alters a distance between the second end portion of thelongitudinal member and the rotatable structure.

In some applications of the present invention, the rotatable structureincludes a spool, and the longitudinal member is coupled at at least thefirst end portion thereof to the spool and is wrapped around the spoolin response to rotation of the spool in a first direction.

In some applications of the present invention, during a first period:

-   -   the elongate tool is configured to maintain the protrusion in a        position in which it is dislodged from the recess, and    -   the elongate tool is configured to rotate the spool, and during        a second period:    -   the elongate tool is configured to remove the elongate tool from        the channel and to position the protrusion in the recess, and    -   the spool is restricted from being rotated.

In some applications of the present invention, the apparatus includes animplant, and,

-   -   the spool is coupled to at least a portion of the implant,    -   and the longitudinal member is disposed in communication with        the implant and coupled at at least a first end thereof to the        spool, and    -   in response to rotation of the spool in a first direction        thereof, the flexible member is configured to be wound around        the spool, and, responsively, to contract the implant.

In some applications of the present invention, in the longitudinalmember is configured to be unwound from around the spool and tofacilitate expansion of the implant in response to rotation of the spoolin a second direction thereof that is opposite the first direction.

In some applications of the present invention, a second end of thelongitudinal member is not coupled to the spool.

In some applications of the present invention, the implant includes acompressible element shaped to define a lumen thereof, and thelongitudinal member is disposed within the lumen of the compressibleelement.

There is further yet provided in accordance with some applications ofthe present inventions, apparatus for adjusting at least one dimensionof an implant, including:

a rotatable structure having a first end shaped to define a firstopening, and a second end shaped to define a second opening and having alower surface thereof, the rotatable structure being shaped to define:

-   -   a channel extending from the first opening to the second        opening, the channel being configured for passage therethrough        of an elongate tool, and    -   a first coupling at the lower surface of the second end thereof;        and

a mechanical element having a surface coupled to the lower surface ofthe rotatable structure, the mechanical element being shaped to provide:

-   -   a second coupling configured to engage the first coupling during        a resting state of the mechanical element, in a manner that        restricts rotation of the rotatable structure, and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to disengage the first and        second couplings in response to a force applied thereto by the        elongate tool.

There is yet additionally provided in accordance with applications ofthe present invention, an annuloplasty structure configured forimplantation along an annulus of a mitral valve of a heart of a subject,the structure including:

a first portion that is flexible and longitudinally compressible; and

a second portion in series with the first portion, the second portionbeing flexible and less longitudinally compressible than the firstportion, and having first and second ends thereof and a body portionbetween the first and second ends, the annuloplasty structure beingconfigured for implantation along the annulus in a manner in which:

-   -   the first end of the second portion is configured to be coupled        to the annulus in a vicinity of a left trigone adjacent to the        mitral valve,    -   the second end of the second portion is configured to be coupled        to the annulus in a vicinity of a right trigone adjacent to the        mitral valve, and    -   the body portion of the second portion is configured to be        disposed along the annulus in a vicinity of the annulus that is        between the left and right trigones.

In some applications of the present invention, the body portion is notcompressible.

In some applications of the present invention, a radius of curvature ata center of the first portion is smaller than a radius of curvature at acenter of the second portion, when no external force is applied to theannuloplasty structure.

In some applications of the present invention, the annuloplastystructure includes an annuloplasty ring.

In some applications of the present invention, the annuloplastystructure includes a partial annuloplasty ring.

In some applications of the present invention, the body portion disposedbetween the first and second ends of the second portion has a length of10-50 mm.

There is also additionally provided, in accordance with someapplications of the present invention:

a rotatable structure having a first end shaped to define a firstopening, and a second end shaped to define a second opening and having alower surface thereof, the rotatable structure being shaped to define:

-   -   a channel extending from the first opening to the second        opening, and    -   a first coupling at the lower surface of the second end thereof;

a mechanical element having a surface coupled to the lower surface ofthe rotatable structure, the mechanical element being shaped to provide:

-   -   a second coupling configured to engage the first coupling during        a resting state of the mechanical element, in a manner that        restricts rotation of the rotatable structure, and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to disengage the first and        second couplings; and

a delivery tool configured to deliver the rotatable structure to atissue site of a patient, the delivery tool including:

-   -   at least a first rotatable knob;    -   a torque-delivering tool coupled to the first rotatable knob,        the torque-delivering tool being shaped to define a        torque-delivering-tool lumen;    -   a screwdriver head coupled to the torque-delivering tool at a        distal end thereof, the screwdriver head being shaped to define        a screwdriver head and configured to rotate the rotatable        structure in response to toque delivered to the screwdriver head        by the torque-delivering tool in response to rotation of the        first rotatable knob; and    -   an elongate tool coupled to the knob at a proximal end, the        elongate tool being slidably coupled to the delivery tool and        disposed at least in part within the torque-delivering-tool        lumen, the elongate tool:        -   having a proximal end coupled to the first rotatable knob            and,        -   having a distal end thereof being advanceable distally,            responsively to a distal pushing of the first rotatable            knob, through the screwdriver head lumen and through the            channel of the rotatable structure, the distal end of the            elongate tool being configured to move the depressible            portion in a manner in which the elongate tool disengages            the first and second couplings.

There is yet provided, in accordance with some applications of thepresent invention, a method, including:

coupling a delivery tool to a rotatable structure by rotating arotatable knob of the delivery tool and screwing a screwdriver head ofthe delivery tool to a proximal portion the rotatable structure withoutrotating the rotatable structure, the rotatable structure having a firstend shaped to define a first opening, and a second end shaped to definea second opening and having a lower surface thereof, the rotatablestructure being shaped to define a channel extending from the firstopening to the second opening, and at least one first coupling at thelower surface of the second end thereof,

subsequently to the coupling, disengaging a second coupling from withinthe at least one first coupling of the rotatable structure by:

-   -   pushing distally the rotatable knob,    -   pushing distally a distal end of an elongate tool through the        channel of the rotatable structure and beyond the second opening        of the rotatable structure,    -   responsively to the pushing distally of the distal end of the        elongate tool, moving a depressible portion that is coupled to        the second coupling and disposed in communication with the        second opening of the lower surface of the rotatable structure;        and

subsequently to the disengaging, rotating the rotatable structure byrotating at least a portion of the delivery tool.

There is also provided, in accordance with some applications of thepresent invention, apparatus for adjusting at least one dimension of animplant, including:

a rotatable structure having a first end shaped to define a firstopening, and a second end shaped to define a second opening and having alower surface thereof, the rotatable structure being shaped to define:

-   -   a channel extending from the first opening to the second        opening, the channel being configured for passage therethrough        of an elongate tool, and    -   at least one first coupling at the lower surface of the second        end thereof; and

a mechanical element having a surface coupled to the lower surface ofthe rotatable structure, the mechanical element being shaped to provide:

-   -   a second coupling configured to engage the first coupling during        a resting state of the mechanical element, in a manner that        restricts rotation of the rotatable structure, and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to disengage the at least        one first coupling and the second coupling in response to a        force applied thereto by the elongate tool.

There is also provided, in accordance with some applications of thepresent invention, the following inventive concepts:

1. A method, comprising:

providing an implant structure having first and second portions thereof,the implant structure including:

-   -   a spool coupled to the implant structure in a vicinity of the        first portion of the structure; and    -   a flexible member coupled at a first end thereof to the spool,        and not coupled at a second end thereof to the spool;

advancing the implant structure, in a first configuration thereof,toward an annulus of the subject;

coupling the structure to the annulus; and

rotating the spool, and thereby:

-   -   winding a portion of the flexible member around the spool;    -   contracting the implant structure by pulling on the second end        of the flexible member and thereby drawing the first and second        portions of the implant structure toward each other; and

contracting the annulus.

2. The method according to inventive concept 1, wherein coupling thestructure to the annulus comprises:

coupling the structure to a mitral valve of the annulus;

coupling the first portion of the implant structure to a first locationalong the annulus in a vicinity of a first trigone adjacent to themitral valve; and

coupling the second portion of the implant structure to a secondlocation along the annulus in a vicinity of a second trigone adjacent tothe mitral valve.

3. The method according to inventive concept 1, wherein advancing theimplant structure comprises transcatheterally advancing the implantstructure.4. The method according to inventive concept 1, wherein advancing theimplant structure in the first configuration comprises advancing theimplant structure in a linear configuration thereof.5. The method according to inventive concept 1, wherein contracting theimplant structure comprises rotating the spool in a first directionthereof, and wherein the method further comprises expanding the implantstructure by rotating the spool in a second direction thereof that isopposite the first direction.6. The method according to inventive concept 1, wherein advancing theimplant structure in the first configuration comprises forming thestructure into a curved configuration and advancing the implantstructure in the curved configuration thereof7. The method according to inventive concept 6, wherein advancing theimplant structure in the first configuration comprises forming thestructure into a substantially closed curved configuration and advancingthe implant structure in the closed curved configuration thereof8. The method according to inventive concept 6, further comprisingcoupling a plurality of sutures to the annulus along at least a portionof a circumference thereof, wherein:

forming the structure into the curved configuration comprises couplingthe plurality of sutures to respective portions of the implantstructure; and

advancing the implant structure in the curved configuration thereofcomprises advancing the implant structure along the plurality ofsutures.

9. A method, comprising:

providing a rotatable structure coupled to a mechanical locking elementhaving a surface coupled to a lower surface of the rotatable structure;

implanting the rotatable structure in cardiac tissue;

advancing an elongate tool through a channel provided by the rotatablestructure;

unlocking the rotatable structure from the mechanical locking element bypushing a depressible portion of the surface of the locking element;

responsively to the pushing of the depressible portion, dislodging aprotrusion protruding out of a plane of the surface of the mechanicalelement from within a recess defined by the rotatable structure; and

in response to the dislodging, rotating the rotatable structure.

10. The method according to inventive concept 9, wherein implanting therotatable structure in the cardiac tissue comprises implanting therotatable structure at an intraventricular site, such that the rotatablestructure is disposed in a ventricular lumen of the ventricle and aportion of the rotatable structure does not extend beyond a pericardiumof a heart of the patient.11. The method according to inventive concept 9,

wherein rotating the rotating structure comprises, during a firstperiod,

facilitating the rotating of the rotating structure by:

-   -   pushing the depressible portion; and    -   maintaining the protrusion in a position in which it is        dislodged from the recess, and

wherein the method further comprises, during a second period:

-   -   removing the elongate tool from within the channel and        facilitating

positioning of the protrusion in the recess; and

-   -   restricting rotation of the rotatable structure.        12. The method according to inventive concept 11, wherein        rotating the rotatable structure comprises rotating the        rotatable structure in first and second directions, the first        direction being opposite the second direction.        13. The method according to inventive concept 9, wherein        rotating the rotatable structure comprises rotating the        rotatable structure in a first direction, and wherein the method        further comprises advancing a first end portion of a        longitudinal member in a first direction with respect to the        rotatable structure, responsively to the rotating of the        rotatable structure in the first direction.        14. The method according to inventive concept 13, further        comprising:

rotating the rotatable structure in a second direction; and

responsively to the rotating of the rotatable structure in the seconddirection, advancing the first end portion of the longitudinal member ina second direction with respect to the rotatable structure, the seconddirection being opposite the first direction.

15. The method according to inventive concept 13, wherein:

the longitudinal member adjusts at least one dimension of an implantincluding an annuloplasty device,

a second end portion of the longitudinal member is coupled to at leastone end portion of the annuloplasty device, the end portion beingselected from the group consisting of: a first end portion of theannuloplasty device and a second end portion of the annuloplasty device,and

the method further comprises adjusting the at least one dimension of theimplant responsively to the rotating by altering a distance between thesecond end portion of the longitudinal member and the rotatablestructure.

16. The method according to inventive concept 13, wherein advancing thefirst end portion of the longitudinal member in the first directioncomprises wrapping at least a portion of the first end portion of thelongitudinal member around the rotatable structure.17. The method according to inventive concept 16, further comprising:

rotating the rotatable structure in a second direction opposite thefirst direction; and

unwrapping the at least a portion of the first end portion of thelongitudinal member from around the rotatable structure.

18. The method according to inventive concept 13, further comprisingcoupling a second end portion of the longitudinal member to a portion oftissue of a heart of a patient, and wherein advancing the first endportion of the longitudinal member comprises drawing the portion oftissue and the rotatable structure toward each other.19. The method according to inventive concept 18, wherein coupling thesecond end portion of the longitudinal member to the portion of tissueof the heart of the patient comprises coupling the second end portion ofthe longitudinal member to at least one leaflet of an atrioventricularvalve of the patient, and wherein advancing the first end portion of thelongitudinal member comprises drawing the at least one leaflet and therotatable structure toward each other.20. A method, comprising:

providing a rotatable structure, and a mechanical locking element thatis coupled to a lower surface of the rotatable structure;

implanting the rotatable structure in cardiac tissue;

advancing an elongate tool through a channel provided by the rotatablestructure;

unlocking the rotatable structure from the mechanical locking element bypushing a depressible portion of the locking element;

responsively to the pushing of the depressible portion, dislodging afirst coupling provided by the rotatable structure from a secondcoupling provided by the mechanical element; and

in response to the dislodging, rotating the rotatable structure.

21. A method, comprising:

providing an annuloplasty structure having:

-   -   a first portion that is flexible and longitudinally        compressible; and    -   a second portion in series with the first portion, the second        portion being flexible and less longitudinally compressible than        the first portion, and having first and second ends thereof and        a body portion disposed between the first and second ends;

implanting the annuloplasty structure along an annulus of a valve of asubject by:

-   -   coupling the first end of the second portion to the annulus in a        vicinity of a left trigone adjacent to the valve;    -   coupling the second end of the second portion the annulus in a        vicinity of a right trigone adjacent to the valve; and    -   coupling the body portion of the second portion along the        annulus in a vicinity of the annulus that is between the left        and right trigones; and

compressing the first portion of the annuloplasty structure whilesubstantially not compressing the second portion of the annuloplastystructure.

22. The method according to inventive concept 21, wherein providing theannuloplasty ring comprising providing an annuloplasty ring having aradius of curvature at a center of the first portion is smaller than aradius of curvature at a center of the second portion, when no externalforce is applied to the annuloplasty structure.23. The method according to inventive concept 21, wherein providing theannuloplasty structure comprises providing a closed annuloplasty ring.24. The method according to inventive concept 21, wherein providing theannuloplasty structure comprises providing a partial annuloplasty ring.

25. The method according to inventive concept 21, wherein attaching thesecond end of the second portion the annulus comprising attaching thesecond end of the second portion the annulus at a distance between fromthe first end of between 10 and 50 mm.

26. Apparatus, comprising:

a rotatable structure having a first end and a second end, the first endbeing shaped to receive a portion of a tool and having an upper surfacethereof shaped to:

-   -   provide at least a portion thereof having a circumference, and    -   define one or more recesses at respective locations along the        circumference;

a mechanical element having a planar surface coupled to the uppersurface of the rotatable structure, the mechanical element being shapedto provide at least one protrusion protruding out of a plane of theplanar surface of the mechanical element, the protrusion being disposedwithin one of the recesses during a resting state of the mechanicalelement, in a manner that restricts rotation of the rotatable structure;and

a compressible element coupled to the second end of the rotatablestructure, the compressible element being configured to be compressedand facilitate dislodging of the protrusion from within the recess inresponse to a force applied to the rotatable element by the elongatetool.

27. The apparatus according to inventive concept 26, wherein therotatable structure comprises a spool, and wherein the apparatus furthercomprises a flexible member configured to be coupled at at least a firstend thereof to the spool and to be wrapped around the spool in responseto rotation thereof.28. The apparatus according to inventive concept 27, further comprisingan implant, wherein:

the spool is coupled to at least a portion of the implant,

and the flexible member is disposed in communication with the implantand coupled at at least a first end thereof to the spool, and

in response to rotation of the spool in a first direction thereof, theflexible member is configured to be wound around the spool, and,responsively, to contract the implant.

29. The apparatus according to inventive concept 28, wherein theflexible member is configured to be unwound from around the spool and tofacilitate expansion of the implant in response to rotation of the spoolin a second direction thereof that is opposite the first direction.30. The apparatus according to inventive concept 28, wherein a secondend of the flexible member is not coupled to the spool.31. The apparatus according to inventive concept 28, wherein the implantcomprises a compressible element shaped to define a lumen thereof, andwherein the flexible member is disposed within the lumen of thecompressible element.32. A method, comprising:

providing an annuloplasty structure having:

-   -   a first portion that is flexible and longitudinally        compressible; and    -   a second portion in series with the first portion, the second        portion being flexible and less longitudinally compressible than        the first portion, and having first and second ends thereof and        a body portion disposed between the first and second ends;

implanting the annuloplasty structure along an annulus of a valve of asubject by:

-   -   coupling the first end of the second portion to the annulus in a        vicinity of a left trigone adjacent to the valve;    -   coupling the second end of the second portion the annulus in a        vicinity of a right trigone adjacent to the valve; and    -   coupling the body portion of the second portion along the        annulus in a vicinity of the annulus that is between the left        and right trigones; and

compressing the first portion of the annuloplasty structure whilesubstantially not compressing the second portion of the annuloplastystructure.

33. The method according to inventive concept 32, wherein providing theannuloplasty ring comprising providing an annuloplasty ring having aradius of curvature at a center of the first portion is smaller than aradius of curvature at a center of the second portion, when no externalforce is applied to the annuloplasty structure.34. The method according to inventive concept 32, wherein providing theannuloplasty structure comprises providing a closed annuloplasty ring.35. The method according to inventive concept 32, wherein providing theannuloplasty structure comprises providing a partial annuloplasty ring.36. The method according to inventive concept 32, wherein attaching thesecond end of the second portion the annulus comprising attaching thesecond end of the second portion the annulus at a distance between fromthe first end of between 10 and 50 mm.37. Apparatus, comprising:

a rotatable structure having a first end and a second end, the first endbeing shaped to receive a portion of a tool and having an upper surfacethereof shaped to:

-   -   provide at least a portion thereof having a circumference, and    -   define one or more recesses at respective locations along the        circumference;

a mechanical element having a planar surface coupled to the uppersurface of the rotatable structure, the mechanical element being shapedto provide at least one protrusion protruding out of a plane of theplanar surface of the mechanical element, the protrusion being disposedwithin one of the recesses during a resting state of the mechanicalelement, in a manner that restricts rotation of the rotatable structure;and

a compressible element coupled to the second end of the rotatablestructure, the compressible element being configured to be compressedand facilitate dislodging of the protrusion from within the recess inresponse to a force applied to the rotatable element by the elongatetool.

38. The apparatus according to inventive concept 37, wherein therotatable structure comprises a spool, and wherein the apparatus furthercomprises a flexible member configured to be coupled at at least a firstend thereof to the spool and to be wrapped around the spool in responseto rotation thereof.39. The apparatus according to inventive concept 38, further comprisingan implant, wherein:

the spool is coupled to at least a portion of the implant,

and the flexible member is disposed in communication with the implantand coupled at at least a first end thereof to the spool, and

in response to rotation of the spool in a first direction thereof, theflexible member is configured to be wound around the spool, and,responsively, to contract the implant.

40. The apparatus according to inventive concept 39, wherein theflexible member is configured to be unwound from around the spool and tofacilitate expansion of the implant in response to rotation of the spoolin a second direction thereof that is opposite the first direction.41. The apparatus according to inventive concept 39, wherein a secondend of the flexible member is not coupled to the spool.42. The apparatus according to inventive concept 39, wherein the implantcomprises a compressible element shaped to define a lumen thereof, andwherein the flexible member is disposed within the lumen of thecompressible element.43. A method, comprising:

providing a rotatable structure, and a mechanical locking element thatis coupled to a lower surface of the rotatable structure;

implanting the rotatable structure in cardiac tissue;

advancing an elongate tool through a channel provided by the rotatablestructure;

unlocking the rotatable structure from the mechanical locking element bypushing a depressible portion of the locking element;

responsively to the pushing of the depressible portion, dislodging afirst coupling provided by the rotatable structure from a secondcoupling provided by the mechanical element; and

in response to the dislodging, rotating the rotatable structure.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an annuloplasty structure in aresting state thereof, in accordance with some applications of thepresent invention;

FIGS. 2-3 are schematic illustrations of the annuloplasty structure inrespective contracted states thereof, in accordance with someapplications of the present invention;

FIG. 4 is a schematic illustration of the annuloplasty structure of FIG.1 being coupled to an elongate tool, in accordance with someapplications of the present invention;

FIG. 5 is a schematic illustration of the annuloplasty structure, inaccordance with some other applications of the present invention;

FIGS. 6A-B, 7, and 8A-B are schematic illustrations of the contractingmechanism that is used to contract the annuloplasty structure, inaccordance with some applications of the present invention;

FIGS. 9-11, 12A-B, and 13 are schematic illustrations of a method forimplanting the annuloplasty structure of FIGS. 1-4, in accordance withsome applications of the present invention;

FIGS. 14A-C are schematic illustrations of a locking mechanism used tolock the contracting mechanism, in accordance with some applications ofthe present invention;

FIG. 15 is a schematic illustration of an annuloplasty structure forcontracting the annulus, in accordance with some other applications ofthe present invention;

FIGS. 16A-C are schematic illustrations of respective components of anadjusting mechanism of a spool assembly, in accordance with someapplications of the present invention;

FIG. 17 is a schematic illustration of a delivery tool which facilitatesrotation of a rotatable structure in an adjusting mechanism, inaccordance with some applications of the present invention;

FIGS. 18-19 are schematic illustrations of the delivery tool of FIG. 1coupled to the adjusting mechanism, in accordance with some applicationsof the present invention;

FIGS. 20A-C are schematic illustrations of respective components of theadjusting mechanism, in accordance with some applications of the presentinvention;

FIGS. 21A-C are schematic cross-sectional illustrations of the deliverytool of FIG. 1, in accordance with some applications of the presentinvention;

FIGS. 22-23 are schematic illustrations of the delivery tool of FIG. 1at different stages of use thereof, in accordance with some applicationsof the present invention;

FIG. 24 is a schematic illustration of the delivery tool of FIG. 1coupled to the adjusting mechanism which is, in turn, coupled to andfacilitates adjustment of an annuloplasty device, in accordance withsome applications of the present invention;

FIGS. 25A-B are schematic illustrations of the delivery tool of FIG. 1coupled to the adjusting mechanism which is, in turn, coupled to andfacilitates adjustment of an annuloplasty device, in accordance withsome other applications of the present invention;

FIG. 26 is a schematic illustration of the delivery tool of FIG. 1coupled to the adjusting mechanism which comprises a pinion that iscoupled to a rack, in accordance with some applications of the presentinvention;

FIGS. 27A-B and 28 are schematic illustrations of a valve prosthesisassembly, in accordance with some applications of the present invention;

FIG. 29 is a schematic illustration of a contracting member coupled tothe annuloplasty structure, in accordance with some applications of thepresent invention; and

FIGS. 30A-B show a multilumen guide tube coupled at a distal end thereofto the adjusting mechanism, in accordance with some applications of thepresent invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Reference is now made to FIGS. 1-3, which are schematic illustrations ofa system 20 for repairing a dilated annulus of a subject comprising animplant structure, e.g., an annuloplasty structure 22, comprising a bodyportion 24, a flexible contracting longitudinal member 30 (hereinreferred to as “contracting member” or “flexible member”), and aadjusting mechanism 40, in accordance with some applications of thepresent invention. FIG. 1 shows structure 22 in a resting state thereofin which structure 22 defines a linear, elongate structure having alongitudinal axis thereof. At least a portion, e.g., the entirety, ofbody portion 24 comprises a compressible material, e.g., a coiledelement, as shown by way of illustration and not limitation. Forexample, body portion 24 may comprise stent-like struts, or a braidedmesh. Typically, body portion 24 defines a lumen along the longitudinalaxis of structure 22 which houses flexible contracting member 30.Flexible contracting member 30 comprises a wire, a ribbon, a rope, or aband, comprising a flexible metal. Flexible contracting member 30 iscoupled at a first end portion thereof to adjusting mechanism 40 whichis coupled to a first end 21 of structure 22. A second end portion offlexible contracting member 30 is coupled to a second end 23 ofstructure 22. Typically, during the resting state, flexible contractingmember 30 is disposed in parallel with the longitudinal axis ofstructure 22. That is, flexible member 30, for some applications doesnot comprise a continuous band that runs through the entire lumen of theannuloplasty devices described herein, and flexible member 30 has atleast one free end portion.

Typically, flexible contracting member 30 comprises a wire, a cable, ora rope, and taken together with the compressible element of body portion24 and the braided mesh surrounding body portion 24, imparts flexibilityto the entire annuloplasty structure.

Typically, body portion 24 comprises a flexible biocompatible material,e.g., nitinol, stainless steel, platinum iridium, titanium, expandedpolytetrafluoroethylene (ePTFE), or cobalt chrome. In some applicationsof the present invention, body portion 24 is coated with PTFE(Polytetrafluoroethylene). In other applications of the presentinvention, body portion 24 comprises accordion-like compressiblestructures which facilitate proper cinching of the annulus whenstructure 22 is contracted. Body portion 24, when compressed, e.g.,typically along a longitudinal axis of structure 22, enables portions ofannuloplasty structure 22 to contract and independently conform to theconfiguration of the annulus of the mitral valve of a given subject.Thus, the compressible element of body portion 24 facilitatescontraction of the annulus in response to contraction of structure 22.

Typically, flexible contracting member 30 comprises a flexible and/orsuperelastic material, e.g., nitinol, polyester, stainless steel, orcobalt chrome, and is configured to reside chronically within structure22. In some applications of the present invention, flexible contractingmember 30 comprises a braided polyester suture (e.g., Ticron). In someapplications of the present invention, flexible contracting member 30 iscoated with polytetrafluoroethylene (PTFE). In some applications of thepresent invention, flexible contracting member 30 comprises a pluralityof wires that are intertwined to form a rope structure.

Adjusting mechanism 40 comprises a housing 44 which houses a rotatablestructure 2900, or a spool 46. Spool 46 has a cylindrical body that isdisposed perpendicularly with respect to the longitudinal axis ofstructure 22. As shown in FIG. 2, spool 46 is shaped to provide a hole42 for coupling of the first end of flexible contracting member 30thereto and, thereby, to adjusting mechanism 40. For some applicationsof the present invention, spool 46 is shaped to define one or more holes42 configured for looping a portion of contracting member 30therethrough, as described hereinbelow. In such an application: (a) amiddle portion, which defines a first end portion, of contracting member30 is coupled to spool 46 by being looped through one or more holes 42,(b) first and second portions that extend from the first end portionlooped through spool 46 extend toward a second end 23 of structure 22,and (c) first and second free ends of contracting member 30 are coupledto second end 23 of structure 22 and define a second end portion ofcontracting member 30.

Spool 46 is shaped to define a channel 48 which extends through thecylindrical portion of spool 46 from an opening provided by an uppersurface 150 of spool 46 to an opening provided by a lower surface 152 ofspool 46. Channel 48 provides a lumen which is disposed along an axisthat is perpendicular to the longitudinal axis of structure 22 in itselongate, linear configuration. As described hereinbelow, a distalportion of a screwdriver engages spool 46 via channel 48 and rotatesspool 46 in response to a rotational force applied to the screwdriver.The rotational force applied to the screwdriver rotates spool 46 via theportion of the screwdriver that is disposed within channel 48 of spool46.

FIG. 2 shows partial contraction of structure 22 in response to arotational force applied to spool 46. In response to the rotationalforce, a portion of flexible contracting member 30 is wrapped aroundspool 46, as shown in the enlarged image of FIG. 2. That is, duringrotation of rotatable structure 2900 in a first direction, successiveportions of member 30 contact spool 46. As flexible contracting member30 is wrapped around spool 46, the second end of member 30 is pulledtoward adjusting mechanism 40 in the direction as indicated by thearrow. Pulling the second end of flexible contracting member 30 towardmechanism 40 pulls second end 23 of structure 22 toward first end 21 ofstructure 22, in the direction as indicated by the arrow. Responsively,the compressible element of body portion 24 is longitudinallycompressed, thereby contracting structure 22.

It is to be noted that the linear structure 22 contracts to form acurved structure 22, as shown, by way of illustration and notlimitation. In some applications of the present invention, contractionof structure 22 forms the structure into a curved configuration.Alternatively, structure 22 is made to assume the curved configurationprior to contracting thereof, and during the contracting, the curvedstructure is contracted. That is, without being formed into a curvedconfiguration prior to the contracting, structure 22 is compressedlinearly along the longitudinal axis thereof.

In some applications of the present invention, the contracting ofstructure 22 enables structure 22 to assume the configuration shown.Alternatively, or additionally, prior to contraction, structure 22 isanchored, or otherwise fastened, at least in part to the annulus of thevalve of the subject at respective locations along structure 22. Theanchoring, or otherwise fastening, of structure 22 to the annulusenables structure 22 to assume the configuration shown, as describedhereinbelow.

FIG. 3 shows further contraction of structure 22 in response tocontinued rotation of spool 46. As shown in the enlarged image of FIG.3, a larger portion of flexible contracting member 30 is wrapped aroundspool 46 (i.e., member 30 is looped many times around element 46), ascompared with the portion of flexible contracting member 30 that iswrapped around spool 46 (as shown in the enlarged image of FIG. 2).Responsively to the wrapping of flexible contracting member 30 aroundspool 46, the compressible element of body portion 24 is furtherlongitudinally compressed, and structure 22 is further contracted. Assuch, structure 22 provides an adjustable partial annuloplasty ring.

Reference is now made to FIGS. 1-3. First end 21 of structure 22comprises a coupling member 31 which couples a first end of body portion24 to adjusting mechanism 40. Typically, the first end of body portion24 is welded to coupling member 31. Adjusting mechanism 40 is coupled toa first suture fastener 41 that is shaped to define a hole 43 forpassage therethrough of a suture. Second end 23 of structure 22comprises a second suture fastener 37 that is shaped to define a hole 47for passage therethrough of a suture. Second end 23 of structure 22comprises a coupling member 33 which couples a second end of bodyportion 24 to suture fastener 37. Typically, the second end of bodyportion 24 is welded to coupling member 33.

Reference is now made to FIG. 4, which is a schematic illustration ofsystem 20 comprising an elongate tool 70 that is reversibly coupled toadjusting mechanism 40 of structure 22, in accordance with someapplications of the present invention. Tool 70 comprises an elongatebody portion 76 which houses a flexible rod 78 that is coupled at adistal end thereof to a screwdriver head 75. Typically, rod 78 functionsas a screwdriver which applies force to screwdriver head 75 (that isdisposed within channel 48 of spool 46) in order to rotate spool 46, andthereby facilitate contraction of structure 22. A proximal portion oftool 70 comprises rotatable structures 72 and 74 which rotate withrespect to each other and cause flexible rod 78 to rotate with respectto body portion 76.

(In this context, in the specification and in the claims, “proximal”means closer to the orifice through which tool 70 is originally placedinto the body of the subject, and “distal” means further from thisorifice.)

In some applications of the present invention, tool 70 is coupled to anannuloplasty sizer and the annuloplasty structure is wrapped around atleast a portion of the sizer. Once wrapped around the sizer, theflexible member is contracted such that the annuloplasty structure hugsand is stabilized around the sizer. The sizer helps position theannuloplasty structure along the annulus and stabilize the structure asit is being contracted.

Typically, tool 70 facilitates the advancement of structure 22 andsubsequent contraction thereof. The distal portion of tool 70 comprisesa housing 82 which surrounds housing 44 of structure 22 and stabilizeshousing 44 during the advancement and contraction of structure 22.Flexible rod 78 is coupled at a distal end thereof to screwdriver head75. Screwdriver head 75 is shaped to define a distal protrusion 71 whichis disposed within channel 48 of spool 46 during the advancement ofstructure 22 toward the annulus of the subject, and during thecontraction of structure 22.

In some applications of the present invention, an advancement tool otherthan tool 70 is used to facilitate advancement of structure 22 towardthe annulus, e.g., the tool described hereinbelow with reference toFIGS. 17-26. Following coupling of structure 22 to the annulus, theadvancement tool is decoupled from structure 22 and extracted fromwithin the body of the subject. Subsequently, tool 70 may be advancedtoward housing 44 of structure 22 and facilitate contraction ofstructure 22. In such applications of the present invention, theadvancement tool may be coupled at a distal end thereof to anannuloplasty sizer and structure 22 is tightened around the sizer duringthe advancement of structure 22 toward the annulus.

A distal portion of protrusion 71 rests against a depressible portion 28of a locking mechanism 45. Typically, locking mechanism 45 comprises amechanical element having a planar surface that is coupled to spool 46.In some applications of the present invention, at least a portion ofmechanism 45 is coupled to, e.g., soldered to or disposed adjacently to,housing 44. Typically, lower surface 152 of spool 46 is shaped to defineone or more (e.g., a plurality, as shown) of recesses, e.g., holes (notshown for clarity of illustration). Locking mechanism 45 is shaped toprovide a protrusion 56, or a first coupling, which protrudes out of theplane of the planar surface of the mechanical element of mechanism 45and into one of the recesses, or a second coupling, of lower surface 152of spool 46, as described hereinbelow.

It is to be noted that the planar, mechanical element of lockingmechanism 45 is shown by way of illustration and not limitation and thatany suitable mechanical element having or lacking a planar surface butshaped to define at least one protrusion may be used together withlocking mechanism 45.

The enlarged image in FIG. 4 shows a cross-section of spool 46 andlocking mechanism 45 in a resting state thereof in which protrusion 56of locking mechanism 45 is disposed within one of the recesses of lowersurface 152 of spool 46. In such a configuration, protrusion 56 locks inplace spool 46 and restricts rotation thereof.

Protrusion 56 remains disposed within the recess of lower surface 152 ofspool 46 until a force is applied to locking mechanism 45 which causesprotrusion 56 to be dislodged from within the recess of lower surface152 of spool 46. Typically, protrusion 56 is coupled to depressibleportion 28 of locking mechanism 45. As described hereinbelow, tool 70 ispushed distally causes protrusion 71 of screwdriver head 75 to pressdown on depressible portion 28. As a result, protrusion 56 of lockingmechanism 45 is pushed down together with depressible portion 28, and isthereby dislodged from within the recess of lower surface 152 of spool46.

Once spool 46 is released from protrusion 56 of locking mechanism 45,flexible rod 78 of tool 70 is rotated in order to rotate screwdriverhead 75, and thereby spool 46.

Typically, housing 82 of tool 70 functions to provide a reference forceagainst housing 44 of structure 22 during the rotation of rotatingelement 46.

Tool 70 may be used in order to advance structure 22 toward the annulusin an open heart procedure, minimally-invasive procedure, and/or in atranscatheter procedure. For applications in which tool 70 is usedduring a transcatheter procedure, tool 70 comprises a substantiallylonger, more flexible body portion than if used during an open-heart orminimally-invasive procedure. In some applications of the presentinvention, tool 70 is used to advance structure 22 toward the annulus ina linear configuration (as shown), in a curved configuration (i.e., inmanner in which structure 22 defines an annuloplasty band or a partialannuloplasty ring), or in a closed configuration (i.e., a configurationin which second end 23 of structure 22 is coupled to housing 44 suchthat structure 22 defines an annuloplasty ring).

FIG. 5 shows a system 120 for repairing a dilated annulus of a subjectcomprising an annuloplasty structure 122 that defines an annuloplastyring, in accordance with some applications of the present invention.Annuloplasty structure 122 comprises first and second ends 21 and 23,respectively, which are coupled to (e.g., welded to) a housing 144 thathouses adjusting mechanism 40. Housing 144 is shaped to provide firstand second coupling members 31 and 35 which are coupled to first andsecond ends 21 and 23, of structure 122.

In some applications of the present invention, structure 122 comprises alinear, elongate structure in a resting configuration thereof. Prior toimplantation, first and second ends 21 and 23 of structure 122 arewelded or otherwise attached to coupling members 31 and 35,respectively, thereby facilitating the formation of structure 122 into asubstantially ring-shaped structure. As described hereinabove withrespect to structure 22 with reference to FIGS. 1-3, structure 122comprises a body portion 24 defining a lumen for housing flexiblecontracting member 30. Typically, body portion 24 comprises acompressible element. As described hereinabove, a first end of flexiblecontracting member 30 is coupled to adjusting mechanism 40, while asecond end of flexible contracting member 30 is coupled to second end 23of structure 122.

It is to be noted that for some applications of the present invention,flexible contracting member 30 may be coupled at both its first andsecond end portions, e.g., first and second ends, to spool 46 ofadjusting mechanism 40. In some applications of the present invention, afirst end of flexible contracting member 30 is coupled to spool 46 whilea second end of flexible contracting member 30 is coupled to the housingwhich houses spool 46. For some applications, contracting member 30comprises a continuous band that is looped through a portion of spool46.

As shown, structure 122 defines a substantially ring-shapedconfiguration, e.g., a “D”-shaped configuration, as shown, whichconforms to the shape of the annulus of a mitral valve of the subject.Prior to contracting of structure 122, the compressible element of bodyportion 24 is relaxed and structure 122 defines a first perimeterthereof. Structure 122 provides portions 49 which comprise a material ina configuration in which portions 49 are flexible and lesslongitudinally compressible, e.g., not longitudinally compressible, withrespect to the compressible element of body portion 24. Portions 49 areconfigured to be disposed along the fibrous portion of the annulus thatis between the trigones of the mitral valve of the heart when structure122 is anchored, sutured, fastened or otherwise coupled to the annulusof the mitral valve. Portions 49 impart rigidity to structure 122 in theportion thereof that is disposed between the fibrous trigones such thatstructure 122 better mimics the conformation and functionality of themitral valve. That is, during rotation of spool 46, and the concurrentcontraction or expansion of structure 122, energy is not expended oncontracting or expanding portions 49.

Typically, both portions 49 have a combined length of 10-50 mm.

Thus, structure 122 defines a compressible portion and anon-compressible portion. Typically, a radius of curvature at a centerof the compressible portion of body portion 24 is smaller than a radiusof curvature at a center of less-compressible portions 49, when noexternal force is applied to the annuloplasty structure.

It is to be noted that the compressible element of body portion 24 andless-compressible portions 49 comprise flexible coiled elements by wayof illustration and not limitation. For example, the compressibleelement of body portion 24 and less-compressible portions 49 maycomprise stent-like struts, or a braided mesh. In either configuration,portions 49 are chronically longitudinally compressed in a resting stateof structure 122.

Housing 82 of tool 70 is coupled to structure 122 by surrounding housing144. Tool 70 facilitates contracting of structure 122 via adjustingmechanism 40 in a manner as described hereinabove with respect to thecontracting of structure 22 with reference to FIGS. 1-4. Tool 70 isshown as comprising a coupling element 77 which couples screwdriver head75 to flexible rod 78.

Reference is again made to FIG. 5. It is to be noted that, structure 122may be provided independently of less-compressible portions 49. In suchapplications of the present invention, the annuloplasty structurecomprises a fully compressible ring, e.g., a continuous ring.

Reference is again made to FIG. 5. It is to be noted that housing 144may be disposed at any suitable location along structure 122, and notonly in between portions 49. For example, housing 144 may be coupled tothe section of body portion 24 that is compressible. In someapplications of the present invention, housing 144 may be disposed inthe middle of the section of body portion 24 that is compressible. Insome applications of the present invention, housing 144 may be coupledto structure 122 at an interface between a first end of portion 49 andthe section of body portion 24 that is compressible. In suchapplications of the present invention, portions 49 may be combined toform one substantially less-compressible portion having first and secondends that are in series with the compressible portion of body portion24. For some applications, a plurality of housings and adjustingmechanisms 40 described herein may be coupled to the annuloplastystructure. Each adjusting mechanism 40 may be coupled to a respectivecontracting member 30 which controls a respective portion of theannuloplasty structure.

FIGS. 6A-B show a relationship between individual components ofadjusting mechanism 40, in accordance with some applications of thepresent invention. As shown, housing 144 is shaped to provide couplingmembers 31 and 35 for coupling first and second ends of the annuloplastystructure thereto. Adjusting mechanism 40 is shown as comprising housing144, by way of illustration and not limitation. For applications inwhich mechanism 40 comprises housing 44 (described hereinabove withreference to FIGS. 1-4), housing 44 comprises only coupling member 31 onone side, and a suture fastener on the other side of housing 44.

Spool 46 is configured to be disposed within housing 144 and defines anupper surface 150, a lower surface 152 and a cylindrical body portiondisposed vertically between surfaces 150 and 152. Spool 46 is shaped toprovide channel 48 which extends from an opening provided by uppersurface 150 to an opening provided by lower surface 152. The cylindricalbody portion of spool 46 is shaped to define one or more holes 42.Typically, flexible contracting member 30 is coupled to spool 46 viahole 42. In some applications of the present invention, flexiblecontracting member 30 comprises a continuous ring-shaped band whichpasses through hole 42 of spool 46.

Lower surface 152 of spool 46 is shaped to define one or more (e.g., aplurality, as shown) recesses 154 disposed between portions 155 of lowersurface 152. Although four recesses 154 are shown by way of illustrationand not limitation, it is to be noted that any suitable number ofrecesses 154 may be provided, e.g., between 1 and 10 recesses. It is tobe noted that four recesses 154 are shown by way of illustration and notlimitation and that any suitable number of recesses 154 may be provided.

Locking mechanism 45 is coupled to lower surface 152. In someapplications of the present invention, at least a portion of lockingmechanism 45 is welded to housing 144. For other applications, lockingmechanism 45 rests against spool 46 and is held in place with respect tospool 46 by a distal cap, as described hereinbelow. Typically, lockingmechanism 45 defines a mechanical element having a planar surface thathas at least one slit 58. Locking mechanism 45 is shaped to provide aprotrusion 56 which projects out of a plane defined by the planarsurface of the mechanical element. Slit 58 defines a depressible portion28 of locking mechanism 45 that is disposed in communication withprotrusion 56. Depressible portion 28 is moveable in response to a forceapplied thereto typically by tool 70, as described hereinabove, and asshown in detail hereinbelow with reference to FIGS. 8A-B.

Reference is now made to FIGS. 6A-B. It is to be noted that lockingmechanism 45 may be coupled to housing 44 as described hereinabove withreference to FIGS. 1-4.

FIG. 7 is a schematic illustration adjusting mechanism 40 and componentsof tool 70 that is configured to be coupled to adjusting mechanism 40,in accordance with some applications of the present invention. Tool 70comprises body 76, e.g., a sleeve, and a flexible, rotatable rod 78disposed within a sleeve provided by body 76. A coupling element 77couples screwdriver head 75 to flexible rod 78. Typically, screwdriverhead 75 is shaped to define a proximal cylindrical structure which ishoused within a lumen provided by coupling element 77. A distal end ofscrewdriver head 75 is shaped to define a distal insert portion 73 whichis designated for insertion within channel 48 of spool 46. Housing 82 iscoupled to a distal end of tool 70 and functions as a cage whichsurrounds housing 144. Typically, during rotating of spool 46 by tool70, housing 82 provides a reference force which facilitates the applyingof a force to spool 46 by tool 70.

Following sufficient contraction of the annuloplasty structure, tool 70and housing 82 are disengaged from housing 144 of the annuloplastystructure and are extracted from within the heart of the subject.

FIGS. 8A-B are schematic illustrations of the locking and unlocking ofspool 46, in accordance with some applications of the present invention.FIG. 8A shows adjusting mechanism 40 in a locked configuration in whichprotrusion 56 of locking mechanism 45 is disposed within a recess 54 oflower surface 152 of spool 46. FIG. 8B shows the unlocking of spool 46by the dislodging of protrusion 56 from recess 54 of spool 46.

Reference is now made to FIGS. 6A-B, 7, and 8A-B. During a resting stateof the locking mechanism, depressible portion 28 is disposedperpendicularly with respect to a longitudinal axis of channel 48, andprotrusion 56 is disposed within one of recesses 154 and thereby locksspool 46 in place with respect to housing 144 such that rotation ofspool 46 is restricted (FIG. 8A). In the resting state of lockingmechanism 45, the distal portion of protrusion 71 of screwdriver head 75rests against depressible portion 28 of locking mechanism 45.

FIG. 8B shows screwdriver head 75 of tool 70 applying a pushing force tolocking mechanism 45 (in the direction as indicated by the arrow). Thepushing force pushes downward protrusion 71 of screwdriver head 75 suchthat protrusion 71 pushes downward depressible portion 28, e.g.,typically at a non-zero angle with respect to spool 46. Pushing portion28 downward pushes downward protrusion 56 such that it is dislodged fromwithin recess 154 of spool 46, and, thereby unlocking spool 46.Following the unlocking, tool 70 facilitates the rotation of screwdriverhead 75 in order to rotate spool 46.

Channel 48 of spool 46 is shaped to accommodate the dimensions of insert73 and protrusion 71 of screwdriver head 75. Insert 73 is shaped toprovide an upper portion having a width that is wider than theprotrusion 71 coupled thereto. In turn, channel 48 of spool 46 is shapedto accommodate insert 73 and protrusion 71 by defining an upper portionand a lower portion thereof in which the upper portion of channel 48 iswider than the lower portion. The narrower lower portion of channel 48ensures that protrusion 71 is not advanced distally beyond a certainpoint as the narrower lower portion of channel 48 restricts passagetherethrough of the upper, wider portion of insert 73.

It is to be noted that housing 144 and structure 122 are shown in FIGS.6A-B, 7, and 8A-B by way of illustration and not limitation, and thatapplications described herein may be practiced in combination withhousing 44 and/or structure 22.

Reference is again made to FIGS. 6A-B, 7, and 8A-B. Following rotationof spool 46 by tool 70, insert 73 of tool 70 is removed from withinchannel 48 spool 46 by pulling on tool 70, and depressible portion 28returns to its resting state, i.e., perpendicular with respect to thelongitudinal axis of channel 48. As depressible portion 28 returns toits resting state, protrusion 56 is introduced within one of theplurality of recesses 154 of lower surface 152 of spool 46 and therebyrestricts rotation of spool 46.

It is to be noted that an outer sheath surrounds screwdriver portion 75of tool 70 in FIGS. 8A-B. Screwdriver portion 75 is shaped to define aring-shaped portion at a portion thereof that is disposed adjacently tohousing 144. The ring-shaped portion has a diameter that is larger thanthe diameter of the opening provided by housing 144, and therefor isrestricted from passage through housing 144. By pushing on tool 70, thering shaped portion pushes against housing 144 in order to push theannuloplasty structure away from tool 70. As screwdriver portion 75pushes against housing 144, the outer sheath is pulled proximally inorder to pull tool 70 away from the annuloplasty structure.

Reference is now made to FIGS. 9-11, 12A-B, and 13, which are schematicillustrations of a method for implantation of structure 22 of system 20along an annulus 92 of the mitral valve of the subject, in accordancewith some applications of the present invention. Typically, prior toadvancement of the annuloplasty structure toward the annulus, aplurality of sutures are sutured, anchored, fastened, or otherwisecoupled around the annulus. Typically, the sutures are accessible from asite outside the body of the subject. FIG. 9 shows a plurality ofsutures 110, e.g., metal or fabric such as polyester, that are coupledvia respective anchors 108 to respective locations 98, 100, and 102along annulus 92 of the mitral valve. The dilated mitral valve is shownas having anterior leaflet 94 and posterior leaflet 96. Typically, eachsuture 110 is coupled to a respective helical anchor 108. As shown,sutures 110 are looped around a portion of anchors 108. In someapplications of the present invention, sutures 110 may be coupled atrespective distal ends thereof to respective anchors 108. Anchors 108are corkscrewed into tissue of annulus 92, thereby indirectly couplingsutures 110 to annulus 92.

Typically, during transcatheter procedures, sutures 110 are anchored toannulus 92, as shown in FIG. 9. It is to be noted that sutures 110 maybe anchored to the annulus, as shown, during open-heart orminimally-invasive procedures.

It is to be noted that sutures 110 are anchored at locations 98, 100,and 102 by way of illustration and not limitation, and that sutures 110may be anchored or otherwise fastened to any suitable location alongannulus 92. Furthermore, it is to be noted that any suitable number ofsutures 110 may be anchored or otherwise fastened to annulus 92, inaccordance with the size of the dilated mitral valve of the subject. Forexample, between 2 and 20 sutures, typically between 2 and 14 sutures,may be anchored to annulus 92 via respective helical anchors 108.

During open-heart or minimally-invasive procedures to repair the dilatedmitral valve, sutures 110 may be sutured directly to annulus 92 usingtechniques known in the art. Typically, a plurality of sutures aresutured along the entire circumference of the annulus in accordance withthe size of the dilated annulus. In some applications of the presentinvention, adjacently-disposed sutures may overlap in part. In someapplications of the present invention, the sutures are sutured toannulus in a manner in which the suture defines a portion disposed inthe tissue, and first and second portions extending from either side ofthe portion of the suture that is disposed within the tissue. In suchapplications of the present invention, the suture may be sutured to thetissue in a manner in which the first and second portions of the tissueare disposed at a distance, e.g., 4 mm, from each other.

FIG. 10 shows the advancement of structure 22 along sutures 110 andtoward annulus 92. Structure 22 is shown as comprising body portion 24which houses flexible contracting member 30 and is surrounded by abraided mesh 26 (for clarity of illustration, portions of body portion24 are shown as not being surrounded by mesh 26). Typically, bodyportion 24 comprises a compressible element, as described herein.Typically, braided mesh 26 comprises a flexible material, e.g., metal orfabric such as polyester, and is longitudinally compressible. Typically,body portion 24 comprises a compressible element. Mesh 26 compressesresponsively to the compression of the compressible element of bodyportion 24.

Prior to advancement toward annulus 92, structure 22 is coupled to tool70, as described hereinabove. For applications in which structure 22 istranscatheterally implanted along annulus 92, structure 22 may beadvanced linearly through the advancement catheter and pushedtherethrough by tool 70. Typically, the advancement catheter istransseptally advanced toward the left atrium of the heart of thesubject and tool 70 is advanced through the catheter.

In some applications of the present invention, structure 22 may becoupled at respective ends thereof to housing 44 of adjusting mechanism40 such that structure 22 is advanced in a closed, substantiallyring-shaped configuration. For applications in which structure 22 istranscatheterally advanced in a closed configuration, structure 22 maybe folded, or otherwise collapsed, such that it fits within the lumen ofthe advancement catheter.

As shown in FIG. 10, prior to advancement of structure 22 toward theannulus, sutures 110 are threaded through respective portions ofstructure 22 outside the body of the patient. Suture 110 that is suturedto location 98 of annulus 92 is threaded through suture fastener 41.Suture 110 that is sutured to location 100 is threaded through suturefastener 37. Suture 110 that is sutured to location 102 is threadedthrough mesh 26 at a portion along structure 22 that is between ends 21and 23. Since locations 98, 100, and 102 are generally circumferentialabout annulus 92, following the threading of sutures 110 throughstructure 22, structure 22 is shaped (from its original linearconfiguration as shown in FIGS. 1 and 4) into a substantially circular,or curved, configuration, as shown, as it is advanced toward annulus 92.In some applications of the present invention, structure 22 comprises ashape-memory alloy, e.g., nitinol, which enables structure 22 to assumethe configuration as shown, independently of the threading therethroughof sutures 110.

Typically, each suture 110 defines a portion that is looped around aportion of a respective anchor 108, and first and second portionsextending from the looped portion. Respective ends of the first andsecond portions of each suture 110 are accessible from outside the bodyof the subject. As shown, the two portions of respective sutures 110 maybe threaded through fasteners 41 and 37 and through mesh 26.Alternatively, a first portion of each suture 110 may be threadedthrough a respective hole defined by fasteners 41 and 37 and throughmesh 26 while a second portion of each suture 110 may be threaded aroundrespective fasteners 41 and 37 and around mesh 26. In such applicationsof the present invention, following the positioning of structure 22along annulus 92, the first and second portions of sutures 110 are tiedtogether around fasteners 41 and 37, and around mesh 26.

Typically, locations 98 and 100 are by way of illustration and notlimitation, on or adjacently to the trigones of the heart that are nearthe mitral valve. Thus, first and second ends 21 and 23 of structure 22will be disposed on or adjacently to the trigones. In such applicationsof the present invention, a portion of structure 22 is not disposed inan area between the fibrous trigones. In some applications of thepresent invention, respective portions of body portion 24 that aredisposed adjacently to first and second ends 21 and 23 of structure 22are less compressible, e.g., not compressible, as compared to thecompressible element of body portion 24.

It is to be noted that first and second ends 21 and 23 of structure 22are disposed in respective vicinities of the left and right trigones byway of illustration and not limitation, and that respective ends 21 and23 may be coupled to any suitable portion along the annulus. That is,annuloplasty structure 22 may be coupled along the annulus in anysuitable orientation and at any suitable location along the annulus.

Structure 22 is coupled to sutures 130, e.g., metal or fabric, at distalends thereof. As described hereinbelow, sutures 130 facilitate theadvancement of respective anchors toward structure 22 following itsinitial anchoring to annulus 92 via sutures 110. It is to be noted thatonly two sutures 130 are coupled to structure 22 by way of illustrationand not limitation, and that any suitable number of sutures 130 may becoupled to structure 22. Typically, the number of sutures 130 coupled tostructure 22 is determined in accordance with the size of the dilatedannulus, and thereby the number of anchoring sites needed in order toproperly anchor structure 22 to the dilated annulus.

FIG. 11 shows structure 22 following the positioning and initialsuturing thereof to annulus 92. Respective beads 140, 141, and 147 areslid along sutures 110 toward an upper surface of structure 22. Beads140, 141, and 147 each comprise a crimping mechanism which crimpssutures 110 and, thereby beads 140, 141, and 147 lock sutures 110 inplace with respect to structure 22, thereby locking in place structure22 with respect to annulus 92. Excess portions of sutures 110 areclipped proximally to beads 140, 141, and 147 and removed from withinthe heart of the subject.

Following the initial locking of structure 22 with respect to annulus92, sutures 130 remain extending from structure 22 and accessible fromoutside the body of the subject. Sutures 130 facilitate advancement ofanchors toward structure 22 in order to further anchor structure 22 toannulus 92 at locations 1120 and 1122. It is to be noted that twosutures 130 are shown by way of illustration and not limitation, andthat any suitable number of sutures 130 may be coupled to structure 22.

Following implantation of structure 22 along annulus 92 and prior tocontraction of structure 22, structure 22 provides a partialannuloplasty ring, or band, having a distance between first and secondends 21 and 23 of structure 22 such that structure 22 defines a firstperimeter thereof.

FIGS. 12A-B show further anchoring of structure 22 to annulus 92. Asheath 1151 has a lumen which houses an anchor advancement tube 1150,which in turn, has a lumen thereof. Sheath 1151 and advancement tube 150are advanced along suture 130 and toward structure 22. A distal end ofanchor advancement tube 1150 is coupled to an anchor which is used toanchor structure 22 to annulus 92. Typically, the anchor is advanced toannulus 92 with respect to structure 22. In some applications of thepresent invention, the anchor is advanced through body portion 24, asshown in FIGS. 12A-B. In some applications of the present invention, theanchors are advanced through braided mesh 26 that surrounds body portion24.

FIG. 12A shows the anchor comprising a helical anchor 108 having apointed distal tip. Anchor 108 is corkscrewed with respect to thecompressible element of body portion 24 such that helical anchor 108intertwines with the compressible element of body portion 24 and isthereby coupled to the compressible element. Further corkscrewing ofhelical anchor 108 advanced a distal portion of anchor 108 beyondstructure 22 and into tissue of annulus 92, thereby further anchoringstructure 22 to annulus 92.

FIG. 12B shows the anchor comprising a pronged anchor 105 having asubstantially rigid, body portion and a plurality of prongs 107 eachhaving a pointed distal end. Body portion of anchor 105 is coupled tostructure 22 and prongs 107 are advanced through tissue of annulus 92.Typically, anchor 105 comprises a shape-memory alloy, e.g., nitinol,which enables prongs 107 to transition from the substantially straightconfiguration, to a curved configuration in which each prong 107 curvesproximally to assume a substantially “U”-shaped configuration, as shown.Typically, during advancement of anchor 105 toward structure 22, anchor105 is disposed within sheath 1151 in a configuration in which prongsare aligned in a straight configuration.

It is to be noted that anchor 105 is shown as comprising two prongs 107by way of illustration and not limitation, and that any suitable numberor prongs may be used.

Typically, anchor 105 is compressed within a tubular housing prior tobeing advanced through tissue of the annulus. The tubular housing isfirst advanced through the annuloplasty structure prior to the pushingof anchor 105 from within the tubular housing and into tissue of theannulus. In some applications of the present invention, the tubularhousing comprises anchor advancement tube 1150 which is first advancedthrough a portion of the annuloplasty structure, e.g., is advancedbetween adjacent coils of the annuloplasty structure, prior to advancinganchor 105 from within tube 150 and into tissue of the annulus. Asanchor 105 penetrates tissue of annulus 92, prongs 107 gradually bendaway from a longitudinal axis of the body portion of anchor 105 in orderto assume their respective bent configurations. As prongs 107 assumetheir respective bent configurations, their pointed ends puncturesurrounding tissue in order to further anchor anchor 105 to tissue ofthe patient. In its expanded, bent configuration, anchor 105 isconfigured to restrict proximal motion of thereof through the tissue.

Once structure 22 is further anchored to annulus 92, a respective bead146 and 148 is advanced along each suture 130 and toward an uppersurface of structure 22 (FIG. 13). Beads 146 and 148 lock in placestructure 22 at locations 1120 and 1122, respectively, in a manner asdescribed hereinabove with respect to beads 140, 141, and 147. Followingthe advancing of beads 146 and 148 toward the upper surface of structure22, excess portions of sutures 130 are clipped proximally to beads 146and 148 and are removed from the heart of the subject.

FIG. 13 shows the contracting annulus 92 in response to the contractingof structure 22. Structure is typically contracted only following thelocking in place structure 22 to annulus 92 by the beads. The flexiblerod housed within tool 70 (as described hereinabove with reference toFIGS. 4-7, and 8A-B) is pushed downward, as shown by arrow 1, in orderto release locking mechanism 45 from spool 46 of adjusting mechanism 40,as described hereinabove. Once free of locking mechanism 45, spool 46 isrotated in response to a rotational force applied thereto by tool 70, asindicated by arrow 2. Rotation of spool 46 contracts structure 22, bywrapping at least a portion of member 30 around spool 46, and therebypulling on the second end of flexible contracting member 30 toward thefirst end of flexible contracting member 30 such that flexible memberpulls on second end 23 of structure 22 toward first end 21 of structure22 (in a direction as indicated by arrow 13), as described hereinabovewith reference to FIGS. 2 and 3. At the same time, first end 21 ofstructure 22 is pulled toward second end 23 of structure 22.

Following the contraction of structure 22, first and second ends 21 and23, respectively, of structure 22 are pulled toward each such thatstructure 22 assumes a second perimeter. The second perimeter followingthe contracting of structure 22 is smaller than the first perimeter ofstructure 22 prior to the contracting. Structure 22 may be contractedsuch that the second perimeter defines any suitable dimension.

It is to be noted that structure 22 may be anchored to annulus 92 suchthat structure 22 is positioned along the entire perimeter of annulus92. Alternatively, structure 22 may be anchored to annulus 92 such thatit is positioned partially along the perimeter of annulus 92.

Reference is now made to FIGS. 14A-C, which are schematic illustrationsof a locking mechanism 200 configured to lock in place adjustingmechanism 40 of the annuloplasty structures described herein, inaccordance with some applications of the present invention. Lockingmechanism 200 is disposed within housing 202, that is similar tohousings 44 and 144 described hereinabove, with the exception that anunderside of a planar upper surface 204 of housing 202 is shaped todefine a plurality of projections 208 which (a) project out of a planedefined by planar upper surface 204 and downward into the body ofhousing 202, and (b) engage spool 246.

FIG. 14A shows components of locking mechanism 200. Upper surface 204 iswelded or soldered to the body of housing 202. A spool 2246, in turn,has an upper portion 252 and a lower portion 250. Upper portion 252 isshaped to provide raised surfaces 255 which define a plurality ofrecesses 254. Although four recesses 254 are shown by way ofillustration and not limitation, it is to be noted that any suitablenumber of recesses 254 may be provided, e.g., between 1 and 10 recesses.In turn, upper surface 204 may be shaped to provide a suitable number ofprojections 208, e.g., between 1 and 10 projections. Lower portion 250of spool 2246 rests against a compressible element 256, e.g., a springor stent-like element (as shown), that is coupled to a lower portion ofhousing 202.

Recesses 254 of upper portion 252 of spool are is shaped to define ascrew-driver-engaging recess 256 extending 0.1-2.0 mm downward from anupper surface of spool 246. Recess 256 provides a means by which atleast a distal portion of an elongate tool engages and facilitatesrotation spool 246. Typically, a distal portion of the elongate tool isadvanced through an opening 206 in upper surface 204 of housing 202prior to engaging spool 246 via recess 256. As shown hereinbelow,opening 206 is shaped to accommodate a size of a screwdriver tool.

Typically, recesses 254 are disposed along a circumference of at least aportion of upper portion 252 of spool 246. Similarly, projections 208 ofupper surface 204 of housing 202 are disposed along a circumference ofat least a portion of upper surface 204 of housing 202.

FIG. 14B shows locking mechanism 200 in a resting state thereof. Lowerportion 250 of spool 246 rests against compressible element 256 in arelaxed, uncompressed state thereof. As such, in the resting state oflocking mechanism 200, upper portion 252 of spool 246 contacts uppersurface 204 of housing 202 in a manner in which projections 208 of uppersurface 204 are disposed within recesses 254 of upper surface 252 ofspool 246. In such a manner, by being disposed within respectiverecesses 254 of spool 246, projections 208 restrict rotation spool 246.

FIG. 14C shows the unlocking of locking mechanism 200 in response to thedisengaging of spool 246 from upper surface 204 of housing 202. A distalportion of an elongate tool 170 is advanced through hole 206 defined byupper surface 204, and subsequently into recess 256 provided by upperportion 252 of spool 246. Tool 170 is shaped to define a distalscrewdriver portion 175 that first within recess 256 of spool 246 thatis defined by grooves 154. As shown in section A-A of FIG. 14B,screwdriver portion 175 is shaped to define an elliptical cross-sectionby way of illustration and not limitation. For example, screwdriverportion 175 is shaped to define a rectangular cross-section. In someapplications of the present invention, screwdriver portion 175 is shapedto define a “T”-shaped cross-section.

Tool 170 is pushed downward, as indicated by arrow 1, thereby pushingdownward spool 246 and, responsively, compressing compressible element256. In response to the compressing of compressible element 256, upperportion 252 of spool 246 is distanced from upper surface 204 of housing202, and thereby, projections 208 are dislodged from within recesses 264of upper portion 252 of spool 246. Once locking mechanism 200 isunlocked and spool 246 is free of projections 208, tool 170 is rotated(in the direction as indicated by arrow 2) in order to rotate spool 246and wrap flexible contracting member 30 therearound, therebyfacilitating contracting of the annuloplasty structure responsively tothe rotating.

Following the rotating of spool 246 and the responsive contracting ofthe annuloplasty structure, tool 170 is pulled away from spool 246,allowing compressible element 256 to assume its relaxed, uncompressedstate. As compressible element 256 assumes its relaxes, uncompressedstate, compressible element 256 pushed spool 246 upwards in a manner inwhich recesses 254 are once again engaged by projections 208 of uppersurface 204 of housing 202. Such engaging locks spool 246 in place andrestricts rotation thereof.

It is to be noted that tool 170 may also be used to expand theannuloplasty structure by rotating in a direction that is opposite thedirection used in order to contract the annuloplasty structure.

FIG. 15 shows a system 1140 comprising an annuloplasty structure 1122comprising adjusting mechanism 40 coupled to one or more flexiblemembers 30, in accordance with some applications of the presentinvention. Structure 1122 comprises a body portion 24 having acompressible element, as described hereinabove. Body portion 24 istypically surrounded by braided mesh 26, as described hereinabove.

It is to be noted that portions of braided mesh 26 are shown for clarityof illustration and that body portion 24 of structure 1122 may beentirely surrounded by braided mesh 26. Adjusting mechanism 40 isdisposed with respect to structure 1122 at a portion thereof that isbetween first and second ends 21 and 23 thereof, e.g., at the center, asshown by way of illustration and not limitation. For some applications,the portions of structure 1122 disposed on either side of adjustingmechanism 40 may comprise distinct segments. It is to be further notedthat adjusting mechanism 40 may be disposed with respect to annuloplastystructure 1122 at any portion thereof (e.g., generally in the middle ofstructure 1122, as shown).

Adjusting mechanism 40 comprises a spool 46 as described hereinabove.Spool 46 of adjusting mechanism 40 of system 1140 is coupled to a firstend 1131 of a first flexible contracting member 1130 and to a first end1133 of a second flexible contracting member 1132. A second end 1135 offirst flexible member 1130 is coupled to first end 21 of structure 1122.A second end 1137 of second flexible member 1132 is coupled to secondend 23 of structure 1122. Flexible members 1130 and 1132 each comprise awire, a ribbon, a rope, or a band, comprising a flexible metal.

During rotation of spool 46 of adjusting mechanism 40, as describedhereinabove, respective portions of first and second flexible members1130 and 1132 are wrapped around spool 46. That is, successive portionsof respective members 1130 and 1132 contact spool 46 during the rotationthereof. Responsively to the winding of the portions of first and secondflexible members 1130 and 1132 around spool 46, second ends 1135 and1137 of flexible members 1130 and 1132, respectively, are pulled towardadjusting mechanism 40. As second ends 1135 and 1137 of flexible members1130 and 1132, respectively, are pulled toward adjusting mechanism 40,first and second ends 21 and 23 of structure 1122 are pulled towardadjusting mechanism 40, thereby drawing together first and second ends21 and 23.

It is to be noted that system 1140 is shown are comprising first andsecond flexible members 1130 and 1132 by way of illustration and notlimitation. For some applications, adjusting mechanism 40 may be coupledto more than two flexible members 30. For other applications, adjustingmechanism 40 of structure 1122 may be coupled to only one flexiblecontracting member 30. In such an application: (1) a first free end ofthe flexible contracting member 30 is coupled to first end 21 ofstructure 1122, (2) a second free end of contracting member 30 iscoupled to second end 23 of structure 1122, and (3) a portion of member30 disposed between the first and second free ends thereof is loopedthrough spool 46 of adjusting mechanism 40. In such an application,rotating spool 46 in a first direction winds a middle portion of member30 around spool 46 such that: (1) successive portions of member 30contact spool, and (2) the first and second free ends of member 30 (andthereby, first and second ends 21 and 23, respectively, of structure1122) are pulled toward adjusting mechanism 40.

FIG. 16A shows a relationship among individual components of adjustingmechanism 40, in accordance with some applications of the presentinvention. Adjusting mechanism 40 is shown as comprising spool housing1042 which defines an upper surface 1041 and a recessed portion 142.Spool 46 is configured to be disposed within housing 1042 and defines anupper surface 150, a lower surface 152 and a cylindrical body portiondisposed vertically between surfaces 150 and 152. Spool 46 is shaped toprovide a driving interface, e.g., a channel 48, which extends from anopening provided by upper surface 150 to an opening provided by lowersurface 152. Channel 48 of the driving interface is shaped to define ahexagonal channel or a channel having another shape. For someapplications, as described herein, a portion of an inner wall of spool46 that defines channel 48 is shaped so as to define a threaded portionfor receiving a threaded screwdriver tool. The cylindrical body portionof spool 46 is shaped to define holes 42 a and 42 b which function asrespective coupling sites for coupling flexible member 30 to spool 46.

Holes 42 a and 42 b may be shaped to define holes, as shown, or slitsthrough which respective portions of flexible member 30 are loopedtherethrough. In some embodiments, the outer surface of spool 46 isshaped so as to define male projections, e.g., knobs or hooks, aroundwhich respective portions of flexible member 30 are ensnared or loopedand thereby coupled to spool 46.

As described hereinabove, locking mechanism 45 is coupled to lowersurface 152 and is coupled, e.g., welded, at least in part to a lowersurface of spool housing 1042. Typically, locking mechanism 45 defines amechanical element having a planar surface that defines slits 58. It isto be noted that the surface of locking mechanism 45 may also be curved,and not planar. Locking mechanism 45 is shaped to provide a protrusion156 which projects out of a plane defined by the planar surface of themechanical element. Slits 58 define a depressible portion 128 of lockingmechanism 45 that is disposed in communication with and extends towardprotrusion 156. Depressible portion 128 is moveable in response to aforce applied thereto typically by screwdriver head 95, as shown indetail hereinbelow with reference to FIGS. 16B-C.

It is to be noted that the planar, mechanical element of lockingmechanism 45 is shown by way of illustration and not limitation and thatany suitable mechanical element having or lacking a planar surface butshaped to define at least one protrusion may be used together withlocking mechanism 45.

A cap 1044 is provided that is shaped to define a planar surface and anannular wall having an upper surface 244 thereof. Upper surface 244 ofthe annular wall is coupled to, e.g., welded to, a lower surfaceprovided by spool housing 1042. The annular wall of cap 1044 is shapedto define a recessed portion 1144 of cap 1044 that is in alignment withrecessed portion 142 of spool housing 1042. For some applications,locking mechanism 45 is not welded to housing 1042, but rather, lockingmechanism 45 is held in place by cap 1044.

FIGS. 16B-C show adjusting mechanism 40 in respective locking statesthereof, in accordance with some applications of the present invention.It is to be noted that contracting member 30 that is typically coupledto spool 46, is not shown for clarity of illustration. FIG. 16B showsadjusting mechanism 40 in an unlocked configuration in which protrusion156 of a locking mechanism 145 is disposed within recessed portion 1144of cap 1044. FIG. 16C shows the locked state of spool 46 by thepositioning of protrusion 156 within a recess 154 of spool 46. It is tobe noted that locking mechanism 145 is similar to locking mechanism 45,as described hereinabove with reference to FIGS. 1-15, with theexception that protrusion 156 and slits 58 of locking mechanism 145 areshaped differently than protrusion 56 and slit 58 of locking mechanism45.

During (1) the delivery of the annuloplasty structure to which adjustingmechanism 40 is coupled toward the implantation site (i.e., the annulusof an atrioventricular valve), (2) the attachment of the annuloplastystructure to the implantation site, and (3) the subsequent bidirectionalrotation of spool 46 to adjust the dimensions of the annuloplastystructure, adjusting mechanism 40 is disposed in an unlocked state, asshown in FIG. 16B. As shown in FIG. 16C, spool 46 is shaped to provide afirst opening 180 at upper surface 150 thereof and a second opening 182at a lower surface 152 thereof. Spool 46 defines a channel 48 thatextends from first opening 180 toward second opening 182.

FIG. 16B shows adjusting mechanism 40 in an unlocked state thereof inwhich screwdriver head 95 is disposed within channel 48 of spool 46.Screwdriver head 95 comprises an elongate body shaped to define aproximal generally cylindrical structure and spool-rotating portion 94which fits within channel 48 defined by spool 46. Spool-rotating portion94 is shaped to define a distal force applicator 93 which is disposedproximally to and in communication with depressible portion 128 oflocking mechanism 145. In the unlocked state of adjusting mechanism 40,screwdriver head 95 is disposed with respect to housing 1042 in a mannerin which a distal end of force applicator 93 extends beyond secondopening 182 of spool 46 and pushes against depressible portion 128 oflocking mechanism 145. Depressible portion 128 is thus pushed downward,as shown.

Channel 48 of spool 46 is shaped to accommodate the dimensions ofspool-rotating portion 94 and force application 93 of screwdriver head95. Spool-rotating portion 94 has a width that is wider than the forceapplicator 93. In turn, channel 48 of spool 46 is shaped to accommodatespool-rotating portion 94 and force application 93 defining an upperportion and a lower portion thereof in which the upper portion ofchannel 48 is wider than the lower portion. The narrower lower portionof channel 48 ensures that force applicator 93 is not advanced distallybeyond a certain point as the narrower lower portion of channel 48restricts passage therethrough of the upper, wider portion ofspool-rotating portion 94. Screwdriver head 95 is shaped to define ashelf portion 91 which rests against upper surface 1041 of spool housing1042. Similarly, spool-rotating portion 94 is shaped to define a shelfportion 143 which rests against a horizontal wall of spool 46 whichdefines a portion of channel 48. During the unlocked state of adjustingmechanism 40, screwdriver head 95 is disposed in a manner in which shelfportion 91 thereof rests against upper surface 1041 of spool housing1042, and shelf 143 of spool-rotating portion 94 rests against thehorizontal wall of channel 48, as shown.

During the unlocked state of adjusting mechanism 40, depressible portion128 is maintained in a pushed state by force applicator 93. In such astate, protrusion 156 of locking mechanism 145 is maintained in a pushedstate toward the planar surface of cap 1044. It is to be noted that thesurface of cap 1044 may also be curved, and not planar. As describedhereinabove, cap 1044 is shaped to provide a recessed portion 1144 forreceiving protrusion 156 in its pushed-down state. As depressibleportion 128 is pushed downward, protrusion 156 is freed from within arecess 154 defined by structural barrier portions 155 of the lowerportion of spool 46. Additionally, protrusion 156 is freed from withinrecessed portion 142 provided by spool housing 1042. Responsively,adjusting mechanism 40 is unlocked, and spool 46 may be rotated byscrewdriver head 95 in either clockwise or counter-clockwise directionsin response to torque delivered to head 95 by torque-delivering tool 26coupled thereto. In response to the torque, spool-rotating portion 94 ofscrewdriver head 95 engages and pushes against the wall defining channel48 in order to rotate spool 46.

Cap 1044 functions to restrict distal pushing of depressible portion 128beyond a desired distance so as to inhibit deformation of lockingmechanism 145. Once adjusting mechanism 40 is implanted in heart tissue,cap 1044 also provides an interface between adjusting mechanism 40 andthe heart tissue. This prevents interference of heart tissue onadjusting mechanism 40 during the locking and unlocking thereof.Additionally, cap 1044 prevents damage to heart tissue by depressibleportion 128 as it is pushed downward.

FIG. 16C shows adjusting mechanism 40 in a locked state thereof in whichlocking mechanism 145 is shown in a resting state thereof. In theresting state of locking mechanism 145, depressible portion 128 isdisposed in a horizontal position (i.e., perpendicularly with respect toa longitudinal axis of channel 48) in response to removal of screwdriverhead 95 from within channel 48 of spool 46. Depressible portion 128 hasa tendency to assume the horizontal position, as shown, and in theabsence of a downward pushing force applied to depressible portion 128by screwdriver head 95, depressible portion 128 returns to itshorizontal position from its pushed-down state, as shown in FIG. 4B. Inthis horizontal position, protrusion 156 of locking mechanism 145 isremoved from recessed portion 1144 of cap 1044 and is returned within arecess 154 of spool 46 and thereby restricts movement of spool 46 andlocks adjusting mechanism 40. Additionally, protrusion 156 of lockingmechanism 145 returns in part within recessed portion 142 of spoolhousing 1042. Thus, recessed portion 142 of spool housing 1042 providessupplemental locking of locking mechanism 145.

Reference is now made to FIG. 17, which is a schematic illustration of asystem 2020 comprising a delivery tool 2022 for delivering an adjustingmechanism comprising a rotatable structure to tissue of a patient andfacilitating rotation of rotatable structure, in accordance with someapplications of the present invention. Reference is now made to FIGS.18-19 which show delivery tool 2022 coupled at a distal portion 2028thereof to adjusting mechanism 40 which comprises rotatable structure2900, in accordance with some applications of the present invention.FIGS. 20A-C are schematic cross-sectional illustrations of delivery tool2022 coupled to adjusting mechanism 40 comprising rotatable structure2900, in accordance with some applications of the present invention.

FIG. 17 is an exploded view of tool 2022 showing the relationship of itscomponents. Tool 2022 has an elongate shaft 2024 and a proximal handleportion 2026. For some applications, and as shown herein, shaft 2024comprises a multilumen shaft, by way of illustration and not limitation.That is, shaft 2024 may be shaped to define only a single central lumenfor passage therethrough of a torque-delivering tool 2050. Typically,shaft 2024 is sized for open-heart and/or minimally-invasive proceduresand comprises a flexible material (e.g., a plastic or a plurality ofstrands of flexible metal such as stainless steel 304 that are bundledtogether) which may be bent to a desired angle. For some applicationsshaft 2024 is sized for transluminal, percutaneous, or endovascular,procedures for delivery of an adjusting mechanism, as described herein.

Proximal handle portion 2026 is shaped to define an ergonomichand-grasping portion 2120 for the physician to grasp and thereby holdtool 2022. Handle portion 2026 comprises a central lumen 2122 thatextends from the distal end of handle portion 2026 toward the proximalend of handle portion 2026. A proximal end portion of shaft 2024 isdisposed within lumen 2122 and is thereby coupled to handle portion2026.

A distal end portion 2028 of shaft 2024 is coupled to, e.g., welded to,an adjusting mechanism holder 2029 which comprises a housing portion2030 for receiving and reversibly coupling adjusting mechanism 40.Holder 2029 is shaped to define a lumen for slidable passagetherethrough of a manipulator 2040 which comprises a distal screwdriverhead 2042. Screwdriver head 2042 is ultimately coupled to rotatablestructure 2900 and facilitates rotation of rotatable structure 2900responsively to the rotation of manipulator 2040. Manipulator 2040 iscoupled at a proximal end thereof to a distal end of torque-deliveringtool 2050 which delivers torque to manipulator 2040 and effects rotationof screwdriver head 2042. As is described herienbelow, a proximal end oftorque-delivering tool 2050 is coupled to the rotating mechanism atproximal handle portion 2026. Shaft 2024 is shaped to define a centrallumen through which torque-delivering tool 2050 passes.

Reference is again made to FIGS. 18-19, which show distal portion 2028of tool 2022 coupled to adjusting mechanism 40. Adjusting mechanism 40comprises a rotatable structure housing 1042 which houses rotatablestructure 2900. For some applications, rotatable structure 2900comprises a spool 2146, by way of illustration and not limitation. It isto be noted that rotatable structure 2900 may comprise any suitablerotatable structure (e.g., a pinion of a rack and pinion, as describedhereinbelow). Rotatable structure 2900 and knobs 2070 and 2090 typicallyrotate about a central axis 2200 of tool 2022.

Reference is now made to FIGS. 1-3, 5, 18, 24, and 25A-B, which areschematic illustrations of tool 2022 coupled to adjusting mechanism 40which is, in turn, coupled to an annuloplasty device 1260, in accordancewith respective applications of the present invention. Typically,adjusting mechanism 40 is configured for adjusting a perimeter ofannuloplasty device 1260. As shown, implant 1260 comprises a fullannuloplasty ring, by way of illustration and not limitation. The fullannuloplasty ring may comprise annuloplasty structure 122 as describedhereinabove with reference to FIG. 5. The scope of the present inventionincludes the use of adjusting mechanism 40 and tool 2022 in order toadjust the perimeter of any suitable annuloplasty device such as a fullannuloplasty ring or a partial, or open, annuloplasty ring. Theannuloplasty device may be implemented using any one of the techniquesdescribed in U.S. patent application Ser. No. 12/341,960 to Cabiri,which issued as U.S. Pat. No. 8,241,351, and which is incorporatedherein by reference. Typically, these techniques describe a full orpartial ring comprising a sleeve, a spool coupled to the sleeve, and aflexible longitudinal contracting member that is coupled to the spooland the sleeve, such that (1) winding the contracting member around thespool tightens the ring, and (2) unwinding the contracting member fromaround the spool relaxes and expands the ring. That is, during rotationof rotatable structure 2900 in a first direction, successive portions ofmember 30 contact spool 2146.

Reference is again made to FIGS. 1-3, 5, 15, 18, 24, and 25A-B. Housing1042 typically comprises first and second coupling members 31 and 35which facilitate coupling of adjusting mechanism to the annuloplastydevice. For applications in which a full annuloplasty ring is adjustedby adjusting mechanism 40 (FIG. 24), coupling members 31 and 35 arecoupled to first and second free ends of an annuloplasty device suchthat the coupling of the free ends to members 31 and 35 forms a fullring. For applications in which a partial annuloplasty device isadjusted by adjusting mechanism 40 (FIGS. 25A-B), housing 1042 comprisesonly one coupling member, and a first free end of the annuloplastydevice is coupled to housing 1042 via the coupling member, and thesecond free end of the partial annuloplasty device is not coupled tohousing 1042. For other applications in which a partial annuloplastydevice is adjusted by adjusting mechanism 40 (e.g., structure 22, asdescribed hereinabove with reference to FIGS. 1-3), depending on thepositioning of housing 1042 with respect to the ring, comprises couplingmembers 31 and/or 35. That is, for applications in which theannuloplasty device comprises structure 22, as described hereinabovewith reference to FIGS. 1-3, the housing of adjusting mechanism 40comprises only coupling member 31. For applications in which theannuloplasty device comprises structure 1122, as described hereinabovewith reference to FIG. 15, the housing of adjusting mechanism 40comprises coupling members 31 and 35.

It is to be noted that adjusting mechanism 40 may be coupled to theannuloplasty device along any portion thereof. For some applications,the flexible longitudinal contracting member comprises an artificialchordea tendinea which is coupled at a first portion to the rotatingmember of adjusting mechanism 40 and at a second portion to a leaflet ofan atrioventricular valve of the patient. In such an application,adjusting mechanism 40 functions to adjust a dimension of the artificialchordea tendinea. Such techniques for artificial chordal adjustment maybe implemented using any one of the techniques described in U.S. patentapplication Ser. No. 12/548,991 to Maisano et al., which issued as U.S.Pat. No. 8,808,368, and which is incorporated herein by reference.

Reference is now made to FIGS. 20A-C, which are schematic illustrationsof adjusting mechanism 40 comprising rotatable structure 2900. Adjustingmechanism 40 is shown as comprising housing 1042 which defines arecessed portion 142. Rotatable structure 2900 in some applications,comprises a spool 2146, as shown, to which is coupled at least a portionof a flexible longitudinal member (not shown for clarity ofillustration). Rotation of the spool 2146 in a first direction winds theportions of the longitudinal member around spool 2146, while rotation ofspool 2146 in a second direction opposite the first direction, unwindsthe portion of the longitudinal member from around spool 2146.

Spool 2146 is disposed within housing 1042 and defines an upper surface150, a lower surface 152 and a cylindrical body portion disposedvertically between surfaces 150 and 152. Spool 2146 is shaped to providea driving interface, e.g., a channel 48, which extends from a firstopening 180 provided by upper surface 150 to a second opening 182provided by lower surface 152. A proximal portion of channel 48 of thedriving interface is shaped to define a threaded portion 2046 which mayor may not be tapered. The cylindrical body portion of spool 2146 isshaped to define one or more holes which function as respective couplingsites for coupling (e.g., looping through the one or more holes, orwelding to spool 2146 in the vicinity of the one or more holes) of anynumber of longitudinal members (not shown for clarity of illustration)to spool 2146.

Lower surface 152 of spool 2146 is shaped to define one or more (e.g., aplurality, as shown) recesses 154 which define structural barrierportions 155 of lower surface 152. It is to be noted that any suitablenumber of recesses 154 may be provided, e.g., between 1 and 10 recesses,circumferentially with respect to lower surface 152 of spool 2146. It isto be noted that recesses 154 may be provided at lower surface 152 in arandom pattern, and are not necessarily circumferentially oriented.

Reference is now made to FIGS. 18 and 20A-C. A locking mechanism 1045 isdisposed in communication with lower surface 152 of spool 2146 anddisposed in communication with at least in part to a lower surface ofspool housing 1042. Typically, cap 1044 maintains locking mechanism inplace with respect to lower surface 152 of spool 2146 and lower surfaceof spool housing 1042. For some applications, locking mechanism 1045 iscoupled, e.g., welded or disposed adjacently, to the lower surface ofhousing 1042. Typically, locking mechanism 1045 defines a mechanicalelement having a planar surface that defines slits 58. It is to be notedthat the surface of locking mechanism 1045 may also be curved, and notplanar. Locking mechanism 1045 is shaped to provide a protrusion 156which projects out of a plane defined by the planar surface of themechanical element. Slits 58 (shown in the enlarged portion of FIG. 18)define a depressible portion 128 of locking mechanism 1045 that isdisposed in communication with and extends toward protrusion 156.Depressible portion 128 is moveable in response to a force appliedthereto typically by an elongate locking mechanism release rod 2060which slides through a lumen 2052 of torque-delivering tool 2050, asshown in detail hereinbelow with reference to FIGS. 21A-C.

It is to be noted that the planar, mechanical element of lockingmechanism 1045 is shown by way of illustration and not limitation andthat any suitable mechanical element having or lacking a planar surfacebut shaped to define at least one protrusion may be used together withlocking mechanism 1045.

A cap 1044 is provided that is shaped to define a planar surface and anannular wall having an upper surface thereof. The upper surface of theannular wall is coupled to, e.g., welded to, a lower surface provided byspool housing 1042. The annular wall of cap 1044 is shaped to define arecessed portion 1144 of cap 1044 that is in alignment with recessedportion 142 of spool housing 1042.

Reference is now made to FIG. 18. Housing 1042 surrounding spool 2146 isshown as not being coupled to cap 1044 for clarity of illustration.However, it is to be noted that housing 1042 as shown in FIG. 18 is, infact, coupled to cap 1044, as shown in FIGS. 20A-C.

Reference is now made to FIGS. 20A-C, which are schematic illustrationsof adjusting mechanism 40 in respective locking states thereof. FIG. 20Cshows adjusting mechanism 40 in an unlocked configuration in whichprotrusion 156 of locking mechanism 1045 is disposed within recessedportion 1144 of cap 1044. FIGS. 20A-B show the locked state of spool2146 by the positioning of protrusion 156 within a recess 154 of spool2146.

Reference is now made to FIGS. 18, 19, 20A-C, and 21A-C. FIGS. 21A-Cshow tool 2022 coupled at distal portion 2028 to adjusting mechanism 40.As shown in FIG. 21A, adjusting mechanism 40 is coupled to a contractingmember 30, as described hereinabove. In some applications, spool 2146 isshaped so as to define one or more holes for looping therethrough, andthereby coupling, of a portion of contracting member 30. As shown in theenlarged cross-sectional image of FIG. 20B, housing 1042 is surroundedby housing portion 2030 of adjusting mechanism holder 2029. Spool 2146is disposed within housing 1042 and a threaded portion of screwdriverhead 2042 is coupled to threaded portion 2046 of channel 48 of spool2146. Manipulator 2040, comprising screwdriver head 2042, is coupled tothe distal end of torque-delivering tool 2050. A proximal end oftorque-delivering tool 2050 is coupled to a rotating mechanism inproximal handle portion 2026 of tool 2022. The rotating mechanismcomprises torque-delivering rotator 2080 which is rotated at differenttimes during a surgical procedure by knobs 2070 and 2090.Torque-delivering-tool rotator 2080 comprises a cylindrical structurewhich is shaped to define a lumen 2077 and an opening at a proximal endthereof. Lumen 2077 of rotator 2080 provides a slidable couplingarrangement for an elongate structural component 2071 that is coupled toknob 2070. One or more pins 2084 are coupled to a distal end ofcomponent 2071. Rotator 2080 is shaped to define one or more slits 2082through which project respective portions of pins 2084 in order tocouple component 2071 to rotator 2080. As the operating physicianrotates knob 2070, structural component 2071 rotates and, sincecomponent 2071 is coupled to rotator 2080 via pins 2084, rotator 2080rotates responsively. A distal portion of rotator 2080 is coupled to aproximal portion of torque-delivering-tool coupler 2086.Torque-delivering-tool coupler 2086 is shaped to define a lumen whichhouses the distal end torque-delivering tool 2050. The distal end oftorque-delivering tool 2050 is typically coupled to, e.g., welded to,torque-delivering tool housing 2086. Torque-delivering tool housing 2086rotates responsively to rotation of rotator 2080. Responsively,torque-delivering tool 2050 rotates, which, in turn, rotates screwdriverhead 2042 and, in turn, rotatable structure 2900.

Prior to delivering and implanting adjusting mechanism 40, delivery tool2022 is coupled to mechanism 40. Housing 2030 of adjusting mechanismholder 2029 surrounds housing 1042 of adjusting mechanism 40, whichprovides initial coupling of tool 2022 to adjusting mechanism 40. Duringthe initial coupling, manipulator 2040 may be pushed proximally, alongcentral axis 2200 of tool 2022, by the force of contact of adjustingmechanism 40 to tool 2022. Manipulator 2040 is coupled to a distal endof torque-delivering tool 2050, which in turn, is coupled at a proximalend thereof to torque-delivering-tool coupler 2086. Torque-deliveringtool 2050 slides within a lumen provided by shaft 2024 of tool 2022.Tool 2022 enables such proximal pushing of manipulator 2040 by providinga tensile spring 2087 around torque-delivering-tool coupler 2086. Asscrewdriver head 2042 contacts adjusting mechanism 40, adjustingmechanism 40 responsively pushes and slides proximally (1) screwdriverhead 2042 (2) manipulator 2040, (3) torque-delivering tool 2050, and (4)torque-delivering-tool coupler 2086. Responsively to the pushing oftorque-delivering-tool coupler 2086, spring 2087 is compressed to enablesuch proximal sliding of (1) screwdriver head 2042 (2) manipulator 2040,(3) torque-delivering tool 2050, and (4) torque-delivering-tool coupler2086.

Following the initial coupling of adjusting mechanism 40 to tool 2022,tool 2022 is then more firmly coupled to adjusting mechanism 40 byscrewing screwdriver head 2042 into threaded portion 2046 of spool 2146of adjusting mechanism 40. By the screwing, screwdriver head 2042 isadvanced distally toward adjusting mechanism 40. This screwing of head2042 is accomplished when the physician rotates knob 2070 (in thedirection as indicated by arrow 1 in FIG. 4B), which, in conjunction,rotates (1) component 2071, (2) rotator 2080, (3) torque-delivering toolhousing 2086, (4) torque-delivering tool 2050, and finally, (5)screwdriver head 2042 of manipulator 2040. Responsively, screwdriverhead 2042 screws into threaded portion 2046 of spool 2146, and thereby,adjusting mechanism 40 is firmly coupled to tool 2022. Once tool 2022 isfirmly coupled to adjusting mechanism 40, tool 2022 (1) frees spool 2146from locking mechanism 1045, and (2) rotates spool 2146, as describedhereinbelow.

Reference is now made to FIGS. 22 and 23, which are schematicillustrations of tool 2022 as it releases spool 2146 from lockingmechanism 1045 and rotates spool 2146, in accordance with someapplications of the present invention. Following the firm coupling oftool 2022 to adjusting mechanism 40, locking mechanism 1045 is releasedin order to allow for rotation of spool 2146 of adjusting mechanism 40.

Reference is now made to FIGS. 17, 19, 20A-C, 21A-C, and 22-23. Knob2070 is shaped to define a groove 2073 (as shown in an enlarged image ofknob 2070 in FIG. 17). A flexible, semi-rigid release clip 2072 iscoupled to knob 2070 and is disposed within groove 2073. Clip 2072 isshaped to define male couplings 2074 at respective distal ends of clip2072. Couplings 2074 function to lock knob 2070 with respect to handle2026 during a pushed state of knob 2070. FIGS. 21A-B show knob 2070 in aresting state thereof, prior to the pushing of knob 2070 along centralaxis 2200 of tool 2022, in which a proximal portion of component 2071 isexposed proximal to lumen 2077 of rotator 2080, couplings 2074 aredisposed proximally to the opening of rotator 2080, and pins 2084 aredisposed in a proximal position within slits 2082 of rotator 2080. FIG.21C shows knob 2070 in a pushed state in which the proximal portion ofcomponent 2071 is disposed within lumen 2077 of rotator 2080, a distalportion of clip 2072 is disposed within a proximal portion of lumen 2077of rotator 2080, and male couplings 2074 are disposed, and locked inplace within respective female couplings 2081 of rotator 2080. Thecoupling of male and female couplings 2074 and 2081 enable knob 2070 toremain in a locked position.

The pushing distally of knob 2070 compresses and applies load to atension spring 2078 that is disposed within knob 2070 and component2071. As shown in the enlarged image of FIG. 21C, a proximal end ofelongate locking mechanism release rod 2060, is coupled to release rodholder 2061, which, in turn, is coupled to component 2071. Pushingdistally of knob 2070 (and thereby component 2071) advances holder 2061distally, which, in turn, pushes distally release rod 2060. Release rod2060 extends through tool 2022 from handle 2026 and toward distalportion 2028 of tool 2022, and is surrounded, for the most part, bytorque-delivering tool 2050. During a resting state of tool 2022 (i.e.,when knob 2070 is not pushed distally), a distal end of rod 2060 isdisposed within torque-delivering tool 2050 proximally to and does notengage adjusting mechanism 40.

It is to be noted that in order to release locking mechanism 1045 fromspool 2146, protrusion 156 should be pushed distally by rod 2060 between0.3 and 1.0 mm, e.g., 0.4 mm. When tool 2022 is decoupled from adjustingmechanism 40 and knob 2070 is disposed in a pushed state, the distal endportion of rod 2060 extends approximately 5 mm beyond the distal end oftool 2022. When adjusting mechanism 40 is coupled to tool 2022, and rod2060 is pushed distally, distal end 2062 of rod 2060 contacts and isimpeded by depressible portion 128 of locking mechanism 1045.Depressible portion 128 is capable of being depressed by an angle of upto 20 degrees, e.g., 7 degrees (i.e., cap 1044 restricts depressing ofportion 128 beyond a certain angle). When the distal portion of rod 2060contacts depressible portion 128, portion 128 restricts rod 2060 fromextending further than 1 mm from second opening 182 of spool 2146. Inorder to compensate for the restricting of the extension of rod 2060beyond a predetermined amount, spring 2078 contracts in order toslightly pull back rod 2060. Spring 2078 thus enables tool 2022 to begenerally exacting in pushing protrusion 156 distally by 0.3-0.5, e.g.,0.4 mm.

Reference is again made to FIGS. 20B-C and 22. In response to thepushing of knob 2070 distally (i.e., in the direction as indicated byarrow 6), release rod 2060 slides distally within lumen 2052 oftorque-delivering tool 2050 such that a distal portion of rod 2060slides through lumen 2044 of manipulator 2040 (lumens 2052 and 2044 areshown in the enlarged image of FIG. 20B), through screwdriver head 2042,and then through channel 48 of spool 2146. A distal end 2062 of rod 2060advances beyond the opening provided by lower surface 152 of spool 2146,and presses distally on depressible portion 128 of locking mechanism1045. Since depressible portion 128 is connected to protrusion 156,pushing distally on depressible portion 128 pushes protrusion 156distally from within recess 154 of spool 2146, thereby freeing spool2146 from locking mechanism 1045 (as shown in FIG. 20C and in theenlarged image of FIG. 22). As protrusion 156 is pushed, it advancesdistally within recessed portion 1144 of cap 1044 and within recessedportion 142 of housing 1042.

It is to be noted that any elongate structure, e.g., a pull-wire, a rod,a thread, rope, or a suture, may be passed through lumen 2052 oftorque-delivering tool 2050 independently of and/or in addition to rod2060. It is to be noted that any elongate structure, e.g., a pull-wire,a rod, a thread, rope, or a suture, may be passed through the lumen ofshaft 2024 independently of and/or in addition to tool 2050.

Typically, tool 2050 comprises a flexible material (e.g., a plastic or aplurality of strands of flexible metal such as stainless steel 304 thatare bundled together). Once protrusion is displaced from within recess154 of spool 2146, and spool 2146 is released from locking mechanism1045, the physician rotates knob 2090 in a first direction thereof, asindicated by arrow 7, in order to rotate spool 2146, as describedhereinbelow. The spool is free to rotate in either clockwise orcounterclockwise direction, as long as protrusion 156 of lockingmechanism 1045 is decoupled from spool 2146. The physician is able tofreely rotate knob 2090 (and thereby spool 2146) without any obstructionfrom locking mechanism 1045 because locking mechanism 1045 is kept in anunlocked state (i.e., protrusion 156 remains outside of the recesses 154of spool 2146) due to the pushed state of tool 2022. During this pushedstate, knob 2070 is maintained in a pushed state as male couplings 2074are coupled to female couplings 2081, and rod 2060 is maintained in astate in which distal end 2062 is disposed distally to the openingprovided by lower surface 152 of spool 2146 and pushes on depressibleportion 128 of locking mechanism 1045, as shown in the enlarged image ofFIG. 22.

Reference is now made to FIGS. 17, 18, 21A-C, and 22. As describedhereinabove, the pushing distally and locking in place of knob 2070releases locking mechanism 1045 from spool 2146. Additionally, thepushing distally of knob 2070 engages the rotating mechanism of tool2022 (which comprises rotator 2080 and torque-delivering-tool coupler2086) with knob 2090. In a resting state of tool 2022, as shown in FIG.18, knob 2070 is disposed in its proximal-most position and pins 2084are disposed within slits 2082 of rotator 2080 proximally to knob 2090.As shown in FIGS. 21A-C, knob 2090 is shaped to define slits 2085 alongrespective portions of the inner wall thereof that defines a lumen inwhich a distal portion of rotator 2080 is disposed.

Slits 2082 of rotator 2080 enable slidable advancement of pins 2084during the distal sliding of component 2071 within lumen 2077 of rotator2080 responsively to pushing distally knob 2070. During the restingstate of tool 2022, as shown in FIGS. 18 and 21A-B, knob 2070 is notpushed and a proximal portion of component 2071 is exposed from withinlumen 2077 of rotator 2080. Pins 2084 are disposed proximally to knob2090, as shown in the enlarged image of FIG. 18. During the pushed stateof knob 2070, pins slide distally along slits 2082 of rotator 2080 andalong slits 2085 of knob 2090.

Sections A-A and B-B of FIG. 21A show slits 2085 of knob 2090 and howpins 2084 pass through slits 2085 of knob 2090. As shown in thecross-section, knob 2090 is shaped to define 4 slits 2085 by way ofillustration and not limitation. That is knob 2090 may be shaped todefine two slits 2085 or one slit 2085. Prior to pushing distally ofknob 2070, pins 2084 are disposed proximally to the proximal ends ofrespective slits 2085. In order to engage pins 2084 with respectiveslits 2085, the physician may need to rotate knob 2070, e.g., by 30degrees. This engaging of pins 2084 within slits 2085 further couplesknob 2090 to rotator 2080. It is to be further noted that tool 2022comprises two pins 2084 by way of illustration and not limitation, andthat any suitable number of pins 2084 may be coupled to tool 2022 inaccordance with the number of slits 2085. For example, if tool 2022 has4 slits, as shown, tool 2022 may comprise between 1 and 4 pins 2084.

Since knob 2090 is coupled to rotator 2080, (and spool 2146 is now freedfrom locking mechanism due to the pushed state of knob 2070, asdescribed hereinabove) rotation of knob 2090 in a first directionthereof (as indicated by arrow 7 in FIG. 22), rotates spool 2146 in thefirst direction. For applications in which spool 2146 is coupled tocontracting member 30, as shown in FIG. 21A, rotation of spool 2146 inthe first direction winds contracting member 30 around spool 2146. Oncefreed from locking mechanism 1045, manipulator 2040 of tool 2022 canrotate spool 2146 bidirectionally. Rotation of knob 2090 in a directionopposite the first direction rotates spool 2146 in the oppositedirection and unwinds contracting member 30 from around spool 2146.

Reference is now made to FIGS. 17, 21C, and 22. Tool 2022 is shaped todefine a helical groove 2092 that is shaped to define an indented track2095. As described hereinabove, knob 2090 is coupled to the rotationmechanism of tool 2022, i.e., to rotator 2080 following the pushing ofknob 2070 and the concurrent engaging and locking in place of pins 2084with slits 2085 of knob 2090 (as shown in FIG. 21C). Knob 2090 iscoupled at a distal end thereof to a tiered, or terraced, screw 2094, asshown in FIG. 21A. A narrow end portion of screw 2094 is disposed withina portion of track 2095 and is helically advanceable distally andproximally responsively to rotation of knob 2090. FIGS. 21C and 22 showtool 2022 prior to rotation of knob 2090 in the first direction (asindicated by arrow 7 in FIG. 22) in which screw 2094 is disposed in aproximal portion of track 2095 of helical groove 2092.

Knob 2090 is coupled at a distal end 2091 thereof to a sliding indicator2100 which is shaped to define a window 2102. Rotation of knob 2090 inthe first direction (as indicated by arrow 7 in FIG. 22) helicallyadvances screw 2094 distally. This motion pushes distally slidingindicator 2100. Sliding indicator 2100 slides distally and proximallyalong a cylindrical body component 2106 responsively to rotation of knob2090 in first and second directions, respectively. Component 2106displays a series of numerical indicators 2104. As indicator 2100 slidesalong component 2106, window 2102 displays one or a portion of one ormore numbers of indicators 2104, in order to indicate the number ofrotations of spool 2146. Typically, in a resting state of tool 2022,indicator 2100 is disposed at a proximal-most position in which window2102 displays the first number in the series of indicators 2104.

Typically, adjusting mechanism 40 is coupled to an annuloplasty device,as described herein (specifically with reference to FIGS. 24 and 25A-B,in accordance with some applications of the present invention), and tool2022 is configured to indicate the number of rotations of spool 2146(i.e., the number of times contracting member 30 winds around spool2146) which corresponds to the contraction of device 1260, when knob2090 is rotated in a first direction thereof (as indicated by arrow 7 inFIG. 22). That is, in such applications, numerical indicators 2104 maycomprise the range of sizes of the valve, e.g., between 24 and 40 by wayof illustration and not limitation. Generally, for applications in whichnumerical indicators range between 1-7, as shown, these numberscorrelate to the range of sizes of the valve, e.g., between 24 and 40.

Reference is now made to FIGS. 17 and 22. The proximal annular portionof sliding indicator 2100 is shaped so as to define a plurality of teeth2093. Knob 2090 is coupled to and houses at a distal end 2091 thereof aplunger 2097 (shown in FIG. 17). As knob 2090 is rotated, plunger 2097rotates along teeth 2093 of the proximal annular portion of indicator2100 and thereby provides an audible indication of the number of timesthe physician rotates knob 2090. For embodiments in which adjustingmechanism 40 is coupled to an adjustable annuloplasty device (asdescribed hereinbelow), the device comprises a compressible elementwhich has a tendency to passively expand as it is being activelycontracted by adjusting mechanism 40. In order to counter the tendencyof the compressible element of the annuloplasty device to expand,plunger 2097 prevents this expansion by providing a resistive force toknob 2090 as it advances along teeth 2093.

Reference is now made to FIG. 23, which is a schematic illustration oftool 2022 following rotation of knob 2090, in accordance with someapplications of the present invention. As described hereinabove, knob2090 is rotated in the first direction in order to helically advancescrew 2094 distally along track 2095 of helical groove 2092.

Reference is now made to FIGS. 17, 21C and 23. Helical groove 2092 isshaped to define a certain number of rotations (e.g., 7, as shown by wayof illustration and not limitation in the figures). A distal end 2096 ofgroove 2092 (shown in FIG. 17) provides a termination point at whichscrew 2094 is restricted from being advanced further distally, androtation of knob 2090 in the first direction is thereby restricted.Restriction of rotation of knob 2090 beyond a predetermined pointrestricts rotation of spool 2146 beyond a predetermined amount ofrotations, e.g., 7 as shown by way of illustration and not limitation.It is to be noted that because knob 2070 is also coupled to rotator2080, rotation of knob 2070 also facilitates rotation of spool 2146.However, rotation of spool 2146 via knob 2070 does not rotate screw 2094along groove 2092, and thereby rotation of spool 2146 is not restrictednor indicated by indicator 2100. Alternatively, rotation of spool 2146using knob 2090 is (1) eventually restricted by the distal end of groove2092, and (2) indicated by sliding indicator 2100.

As knob 2090 is rotated, it advances together with indicator 2100distally along body component 2106 of tool 2022.

Following rotation of spool 2146 responsively to the rotation of knob2090, screw 2094 is disposed at a distal end of groove 2092 (e.g., nearor at distal end 2096 of groove 2092), and indicator 2100 is disposed ata distal position in which window 2102 approaches the distal-most number(i.e., number 7) in the series of numerical indicators 2104, indicating(1) that spool 2146 has been rotated about 7 times, (2) that contractingmember 30 has been wound around spool 2146 about 7 times, and/or (3) thelevel of contraction of the annuloplasty device that is coupled toadjusting mechanism 40 in some applications.

Reference is now made to FIGS. 17, 22, and 23. Rotation of knob 2090 inthe first direction (as indicated by arrow 7 in FIG. 22), and therebyspool 2146, winds a portion of contracting member 30 around spool 2146,(as shown in the enlarged cross-sectional image of FIG. 23). Asdescribed herein, rotation of knob 2090 in the second direction oppositethe first direction advances screw 2094 proximally along groove 2092,and rotates spool 2146 in the second direction thereof. Winding of spool2146 in the second direction unwinds the portion of contracting member30 from around spool 2146 in accordance with the number of rotations ofknob 2090 in the second direction.

Reference is again made to FIGS. 21C and 23. Following rotation of spool2146, tool 2022 is decoupled from adjusting mechanism 40. FIG. 21C showsknob 2070 in a pushed state in which male couplings 2074 of clip 2072are locking in place within female couplings 2081 of rotator 2080 (shownin the enlarged cross-sectional image of FIG. 21C). Additionally, in thepushed state of knob 2070, spring 2078 is compressed. In order to lockspool 2146 in place following rotation of spool 2146 following a desiredlevel of rotation of spool 2146 (and in some applications, a desiredlevel of contraction of an annuloplasty device, as described hereinbelowwith reference to FIGS. 24 and 15A-B), the operating physician pushesinwardly the lateral portions of clip 2072 coupled to knob 2070 in orderto release knob 2070 from its pushed state (FIG. 23). Male couplings2074 of clip 2072 are pushed inwardly as the lateral portions of clip2072 are pushed toward the central axis of tool 2022. This pushing ofmale couplings 2074 inwardly frees male couplings 2074 from withinrespective female couplings 2081 (shown in FIG. 21C). Responsively,spring 2078 expands from its compressed state, and knob 2070 is pushedproximally (in the direction as indicated by arrow 8 in FIG. 23) inresponse to the force of spring 2078. As spring 2078 expands, it pullsproximally release rod holder 2061 and release rod 2060 coupled thereto.As rod 2060 is pulled proximally, it slides proximally within lumen 2052of torque-delivering tool 2050 such that distal end 2062 of rod 2060 nolonger pushed distally depressible portion 128 of locking mechanism 1045(as shown in the enlarged cross-sectional image of FIG. 23).Responsively to the retracting proximally of rod 2060, depressibleportion 128 returns to its resting state and thereby returns protrusion156 into one of the recesses 154 of spool 2146 and back into (1)recessed portion 1144 of cap 1044, and (2) recessed portion 142 ofhousing 1042. Once protrusion 156 is placed in recess 154 of spool 2146,spool 2146 is locked in place by locking mechanism 1045 and isrestricted from being rotated by tool 2022.

In order to release knob 2070, the physician pushes inwardly the lateralportions of clip 2072 and knob 2070 is responsively pushed proximallyfrom the proximal end of knob 2090 by expansion of spring 2078. As knob2070 advances proximally, component 2071 that is coupled to knob 2070slides proximally within lumen 2077 of rotator 2080 and pins 2084 slideproximally along slits 2082 of rotator 2080 and along slits 2085 of knob2090.

The physician then rotates knob 2070 in the direction as indicated byarrow 9 in FIG. 23 (i.e., the direction opposite the direction asindicated by arrow 5 in FIG. 20B) in order to unscrew screwdriver head2042 from threaded portion 2046 of spool 2146. Unscrewing screwdriverhead 2042 from spool 2146 decouples manipulator 2040 from spool 2146.The physician then pulls proximally tool 2022 in order to releasehousing 1042 of adjusting mechanism 40 from within housing portion 2030of adjusting mechanism holder 2029, and thereby decouple tool 2022 fromadjusting mechanism 40.

Reference is now made to FIGS. 1-3, 5, 15, 24, and 25A-B, which areschematic illustrations of systems 2400 and 2450 for repairing a dilatedannulus of a patient comprising an implant structure, e.g., annuloplastydevice 1260, comprising a body portion 24, flexible contracting member30, and adjusting mechanism 40, in accordance with some applications ofthe present invention. FIG. 24 shows device 1260 comprising a fullannuloplasty ring 1270 (e.g., for some applications, ring 1270 comprisesannuloplasty structure 122, as described hereinabove with reference toFIG. 5). FIGS. 25A-B show device 1260 comprising a partial, open, ornon-continuous annuloplasty ring 1280 (e.g., for some applications, ring1280 comprises one or more annuloplasty structures 22, as describedhereinabove with reference to FIGS. 1-3 and 15). At least a portion,e.g., the entirety, of body portion 24 comprises a compressiblematerial, e.g., a coiled element, as shown by way of illustration andnot limitation. For example, body portion 24 may comprise stent-likestruts, or a braided mesh.

Typically, body portion 24 defines a lumen along the longitudinal axisof device 1260 which houses contracting member 30. Contracting member 30comprises a wire, a ribbon, a rope, or a band, comprising a flexiblemetal.

Typically, body portion 24 comprises a biocompatible material, e.g.,nitinol, stainless steel, platinum iridium, titanium, expandedpolytetrafluoroethylene (ePTFE), or cobalt chrome. In some applications,body portion 24 is coated with PTFE (Polytetrafluoroethylene). In someapplications, body portion 24 comprises accordion-like compressiblestructures which facilitate proper cinching of the annulus when device1260 is contracted. Body portion 24, when compressed, e.g., typicallyalong a longitudinal axis of device 1260, enables portions ofannuloplasty device 1260 to contract and independently conform to theconfiguration of the annulus of the mitral valve of a given subject.Thus, the compressible element of body portion 24 facilitatescontraction of the annulus in response to contraction of device 1260.

Typically, contracting member 30 comprises a flexible and/orsuperelastic material, e.g., nitinol, polyester, stainless steel, orcobalt chrome, and is configured to reside chronically within device1260. In some applications, contracting member 30 comprises a braidedpolyester suture (e.g., Ticron). In some applications, contractingmember 30 is coated with polytetrafluoroethylene (PTFE). In someapplications, contracting member 30 comprises a plurality of wires thatare intertwined to form a rope structure.

As shown in FIG. 25A, spool 2146 has a cylindrical body that is disposedperpendicularly with respect to the longitudinal axis of device 1260.Spool 2146 is shaped to define one or more holes 260 for coupling of thefirst end of contracting member 30 thereto and, thereby, to adjustingmechanism 40. Spool 2146 is shaped to define a channel 48 which extendsthrough the cylindrical portion of spool 2146 from an opening providedby upper surface 150 of spool 2146 to an opening provided by a lowersurface 152 of spool 2146. Channel 48 provides a lumen which is disposedalong an axis that is perpendicular to the longitudinal axis of device1260 in its elongate, linear configuration. As described herein,screwdriver head 2042 engages spool 2146 via threaded portion 2046 ofchannel 48 and rotates spool 2146 in response to a rotational forceapplied to screwdriver head 2042. The rotational force applied to thescrewdriver rotates spool 2146 via the portion of the screwdriver thatis disposed within channel 48 of spool 2146.

FIG. 24 shows a system 2400 in which tool 2022 is coupled toannuloplasty device 1260. Typically, for such an application, tool 2022is used for open-heart or minimally-invasive procedures, and shaft 2024comprises a flexible material as described hereinabove, that enablesshaft 2024 to conform to a desired angle when shaft 2024 is bent by theoperating physician. As shown, device 1260 comprises a penetrable sleevecomprising a braided fabric mesh 26. Device 1260 may also comprise acoiled implant in addition to or independently of the sleeve. Ring 1270comprises a compressible portion 24 and less compressible portions 49.This less compressible portion is designated for implantation betweenthe trigones of the heart of the patient. The portion of tissue betweenthe trigones typically does not contract as much as other portions oftissue of the annulus of the valve. Less compressible portions 49 helpminimize the amount of contracting of the ring in areas of the annuluswhich do not lend themselves to being tightened anyway.

A first area of ring 1270 (i.e., a first end of portion 24 that iscoupled to adjusting mechanism 40) comprises a first swivel snap whichis coupled to coupling member 31 of housing 1042, and thereby couples afirst end of body portion 24 to adjusting mechanism 40. A second area ofring 1270 (i.e., a second end of portion 24 that is coupled to adjustingmechanism 40) comprises a second swivel snap which is coupled tocoupling member 35 of housing 1042, and thereby couples a second end ofbody portion 24 to adjusting mechanism 40. Typically, (1) the first endof body portion 24 is welded to the first snap, and the first snap isloosely coupled to coupling member 31, and (2) the second end of bodyportion 24 is welded to the second snap, and the second snap is looselycoupled to coupling member 35. This configuration enables swiveling ofadjusting mechanism 40 with respect to ring 1270, e.g., while ring 1270remains stationary.

FIG. 25A shows ring 1280 in a semi-contracted state thereof in whichring 1280 is contracted from a linear, elongate state having alongitudinal axis thereof. Contracting member 30 is coupled at a firstend thereof to adjusting mechanism 40 which is coupled to a first end 21of ring 1280. A second end of contracting member 30 is coupled to asecond end 23 of ring 1280. Typically, during the resting state,contracting member 30 is disposed in parallel with the longitudinal axisof structure 1280.

FIG. 25A shows partial contraction of ring 1280 in response to arotational force applied to spool 2146. In response to the rotationalforce, a portion of contracting member 30 is wrapped around spool 2146,as shown in the enlarged image of FIG. 25A. As contracting member 30 iswrapped around spool 2146, the second end of member 30 is pulled towardadjusting mechanism 40 in the direction as indicated by the arrow.Pulling the second end of contracting member 30 toward mechanism 40pulls second end 23 of ring 1280 toward first end 21 of device 1260, inthe direction as indicated by the arrow. Responsively, the compressibleelement of body portion 24 is longitudinally compressed, therebycontracting device 1260.

In some applications, the contracting of device 1260 enables device 1260to assume the configuration shown. Alternatively, or additionally, priorto contraction, device 1260 is anchored, or otherwise fastened, at leastin part to the annulus of the valve of the subject at respectivelocations along device 1260. The anchoring, or otherwise fastening, ofdevice 1260 to the annulus enables device 1260 to assume theconfiguration shown, as described hereinbelow.

FIG. 25B shows further contraction of device 1260 in response tocontinued rotation of spool 2146. As shown in the enlarged image of FIG.25B, a larger portion of contracting member 30 is wrapped around spool2146 (i.e., member 30 is looped many times around element 46), ascompared with the portion of contracting member 30 that is wrappedaround spool 2146 (as shown in the enlarged image of FIG. 25A).Responsively to the wrapping of contracting member 30 around spool 2146,the compressible element of body portion 24 is further longitudinallycompressed, and device 1260 is further contracted. As such, device 1260provides adjustable partial annuloplasty ring 1280.

Reference is now made to FIGS. 25A-B. First end 21 of ring 1280comprises a swivel snap which is coupled to coupling member 31 ofhousing 1042 and thereby couples a first end of body portion 24 toadjusting mechanism 40. Typically, the first end of body portion 24 iswelded to the snap, and the snap is loosely coupled to coupling member31 so as to enable swiveling of adjusting mechanism 40 with respect toring 1280, e.g., while ring 1280 remains stationary. Adjusting mechanism40 is coupled to a first suture fastener 41 that is shaped to define ahole 43 for passage therethrough of a suture. Second end 23 of ring 1280comprises a second suture fastener 37 that is shaped to define a hole 47for passage therethrough of a suture. Second end 23 of ring 1280comprises a coupling member 33 which couples a second end of bodyportion 24 to suture fastener 37. Typically, the second end of bodyportion 24 is welded to coupling member 33. Applications as describedherein with reference to FIGS. 25A-B also apply to applicationsdescribed herein with reference to FIGS. 1-3 and 15.

Reference is again made to FIGS. 24 and 25A-C. It is to be noted thatthe winding of member 30 around spool 2146, as shown in FIGS. 25A-Bapplies also to the mode of operation of adjusting mechanism 40 of FIG.24. Techniques and devices described herein may be practiced incombination with techniques and devices comprise any device as describedin U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,“Adjustable partial annuloplasty ring and mechanism therefor,” filed onDec. 22, 2008, which issued as U.S. Pat. No. 8,241,351, and which isincorporated herein by reference.

Reference is now made to FIGS. 20A-C, 24, and 25A-B. Adjusting mechanism40 (and thereby device 1260) is first coupled to tool 2022, as describedhereinabove. That is, first knob 2070 is rotated in order to screwscrewdriver head 2042 into threaded portion 2046 of spool 2146, and thenknob 2070 is pushed distally in order to release protrusion 156 oflocking mechanism 1045 from spool 2146. For some applications, tool 2022places device 1260 on the annulus and device 1260 is then sutured oranchored to the annulus. For other applications, a plurality of suturesare first sutured to the annulus. The plurality of sutures are thenthreaded through mesh 26 of device 1260 and device 1260 is then slidtoward the annulus along the plurality of sutures. Once device 1260 ispositioned on the annulus, the sutures are locked in place or tiedproximally to device 1260, and then the sutures are clipped. Followingthe suturing or anchoring of device 1260 to the annulus, the heart isclosed around shaft 2024 of tool 2022, e.g., using a purse-stringstitch, and the patient is removed from the cardiopulmonary bypass pump.As the heart is beating, the operating physician rotates knob 2090 inorder to rotate spool 2146 in a first direction thereof (as describedhereinabove) in order to wind a portion of contracting member 30 aroundspool 2146. It is to be noted, and as described herein, rotation ofspool 2146 may also be accomplished by rotation of knob 2070. In such acase, indicator 2100 will not be advanced in accordance with rotation ofknob 2070 (i.e., because it is typically advanced as knob 2090 isrotated) and will thus not indicate the number of times contractingmember 30 winds around spool 2146 or the level of contraction of device1260.

Once tool 2022 is disengaged from adjusting mechanism 40 following theadjusting of the dimension of the annuloplasty device, and thereby ofthe annulus of the valve, tool 2022 is extracted from the heart. Holder2029 is shaped so as to define a cone-shaped proximal portion which actsas an obturator to enlarge the opening surrounded by the purse-stringstitch. This shape enables ease and atraumatic extracting of distalportion 2028 of tool 2022. Following the extracting of tool 2022, theopening in the heart is closed, e.g., sutured, and the access site tothe body of the patient is sutured.

Reference is now made to FIG. 26, which is a schematic illustration of asystem 2500 comprising a first flexible portion 813 of an implantstructure that is shaped so as to define a rack 814, in accordance withsome applications of the present invention. In such an application,flexile contracting member 30 comprises first flexible portion 813. Insuch applications, rotatable structure 2900 of adjusting mechanism 40comprises a pinion 812. Geared teeth of pinion 812 matingly engage aplurality of engaging element, e.g., teeth, of rack 814, such that firstportion 813 passes between rotatable structure 2900 and a secondrotatable structure 816 that rotates on an axel 818 that is coupled to asecond portion 820 of the implant structure. Pinion 812 and secondrotatable structure 816 are maintained at an appropriate distance fromeach other using a housing or bracket (not shown, for clarity ofillustration). For example, the housing or bracket may connect the axelsof the rotatable structures on the sides thereof.

Reference is now made to FIGS. 17, 18, 21A-C, 22, and 26. Pinion 812 isshaped so as to define a channel having a proximal threaded portion(similarly to channel 48 of spools 46 and 2146, as describedhereinabove). The distal portion of pinion is coupled to lockingmechanism 1045, as described hereinabove with reference to spools 46 and2146 being coupled to locking mechanism 1045. Adjusting mechanism holder2029 of tool 2022 is coupled to pinion 812 or to a housing surroundingpinion 812. Screwdriver head 2042 engages pinion 812 in a manner similarto the engaging of spool 2146 by screwdriver head 2042. That is,screwdriver head 2042 is screwed into the proximal portion of pinion 812responsively to the rotation of knob 2070. Subsequently, pinion 812 isreleased from locking mechanism 1045 responsively to the pushed state ofknob 2070, as described hereinabove. Rotation of knob 2090 in the firstdirection (as indicated by arrow 7 in FIG. 22) facilitates rotation ofpinion 812 in the first direction enables first portion 813 to passbetween pinion 812 and second rotatable structure 816 in a first lineardirection. Once freed from locking mechanism 1045, manipulator 2040 oftool 2022 can rotate spool 2146 bidirectionally. Rotation of knob 2090in a direction opposite the first direction rotates pinion 812 in theopposite direction and, thereby, first portion 813 passes between pinion812 and second rotatable structure 816 in a second linear directionopposite the first linear direction.

Reference is now made to FIGS. 1, 5, 15, and 26. For applications inwhich the implant structure comprises a full band, such as a fullannuloplasty ring (as shown in FIG. 5), the first and second portions813 and 820 of the implant structure are opposite ends of the samecontinuous structure. For applications in which implant structurecomprises at least one partial band, such as a partial annuloplasty ring(e.g., as shown in FIGS. 1 and 15), the respective portions of first andsecond portions 813 and 820 are coupled near respective ends of asleeve, or themselves define the ring. In either application in whichthe implant structure comprises a full band or a partial band, the bandis surrounded by a braided fabric mesh which facilitates anchoring,suturing, or otherwise coupling the implant structure to the annulus ofthe valve. For some applications, a compressible structure, e.g., acoil, is disposed between a full or partial band and the braided mesh.

It is to be noted that, for some applications, system 2500 describedherein, may be provided independently of second rotatable structure 816.Also, for some applications, the plurality of engaging elements of firstportion 813 are shaped so as to define a plurality of window (i.e., andnot teeth, as shown). As rotatable structure 2900 is rotated, successiveportions of member 30 contact rotatable structure 2900. Geared teeth ofpinion 812 matingly engage the windows of portion 813, such thatsuccessive portions of member 30 pass between rotatable structure 2900and a second rotatable structure 816.

Reference is again made to FIGS. 15 and 26. For some applications,flexible members 1130 and 1132 comprise bands each having respectivefirst ends 1131 and 1133, which each define a respective portion 813(only one portion 813 is shown in FIG. 26 for clarity of illustration).That is, a first portion 813 is disposed with respect to rotatablestructure, as shown in FIG. 26, while a second portion 813 is disposedopposite the first portion 813 (i.e., first portion 813 is disposed at 6o'clock with respect to rotatable structure 2900, while a second portion813 is disposed at 12 o'clock with respect to structure 2900). Asdescribed hereinabove, the second ends of members 1130 and 1132 arecoupled to portions 21 and 23, respectively, of structure 1122. Rotationof rotatable structure 2900, i.e., pinion 812, in a first directionthereof causes portions 813 to advance with respect to rotatablestructure 2900 in a opposite linear directions with respect to eachother such that successive portions of the respective first and secondportions 813 contact structure 2900. That is, rotation of structure 2900in a first direction causes first portion 813 to advance to the right ofstructure 2900 while the second portion 813 advances to the left ofstructure 2900. Rotating structure 2900 in a second direction oppositethe first direction causes first and second portions 813 to advance inreverse directions to those in which they advanced when structure 2900was advanced in the first direction.

Reference is made to FIGS. 27A-B and 28, which are schematicillustrations of a valve prosthesis assembly 900, in accordance with anapplication of the present invention. Valve prosthesis assembly 900comprises a prosthetic heart valve 910 that is couplable to a base ring922. Prosthetic heart valve 910 is used to replace a native diseasedheart valve. Valve 910 comprises a plurality of artificial leaflets 930,which comprise a pliant material. Valve 910 may implement techniquesknown in the artificial valve art, such as described, for example, in USPatent Application Publication 2007/0255400 to Parravicini et al., USPatent Application Publication 2004/0122514 to Fogarty et al., US PatentApplication Publication 2007/0162111 to Fukamachi et al., and/or USPatent Application Publication 2008/0004697 to Lichtenstein et al.

Valve 910 further comprises an annular base 932, to which leaflets 930are coupled. Annular base is configured to be couplable to base ring 922during an implantation procedure. For example, as show in FIG. 28, basering 922 may comprise one or more coupling elements 934, such as clipsor magnets, which are configured to be coupled to corresponding couplingelements on a lower surface of annular base 932 (not visible in thefigures). Alternatively or additionally, annular base 932 may beconfigured to be placed within the opening defined by base ring 922, asshown in FIG. 27A. To hold the annular base coupled to the base ring,the base ring is tightened around the annular base, as shown in FIG.27B, typically using one or more of the techniques described hereinabovefor contracting implant structures.

Base ring 922 implements one or more of the techniques of annuloplastyring 22 described hereinabove. In particular, base ring 922 may becoupled to the annulus of the native diseased valve using the anchoringtechniques described hereinabove. In addition, base ring 922 typicallycomprises a rotatable structure 936, such as a spool, which is typicallyimplemented using techniques described herein. The rotatable structureis arranged such that rotation thereof contracts base ring 922,typically using techniques described herein. Such tightening may serveto couple base ring 922 to annular base 932, as shown in FIG. 27B.Alternatively or additionally, such tightening sets the desireddimensions of the base ring, in order to align the coupling elements ofthe base ring with those of valve 910, thereby enabling tight coupling,such as for the applications described with reference to FIG. 28.

For some applications, base ring 922 comprises a partial ring, as shownin FIG. 28, while for other applications, the base ring comprises a fullring, as shown in FIGS. 27A-B.

Valve prosthesis assembly 900 is typically implanted in a minimallyinvasive transcatheter procedure. The procedure begins with theintroduction and implantation of base ring 922 into the heart, such asusing techniques for implanting annuloplasty ring 22, describedhereinabove with reference to FIGS. 9-11 and 17-26. Prosthetic heartvalve 910 is subsequently introduced into the heart and coupled to basering 922, as described above. Valve prosthesis assembly 900 is typicallyused for replacement of a diseased native mitral valve, aortic valve,tricuspid valve, or pulmonary valve.

FIG. 29 shows a system 1200 in which contracting member 30 is coupled tospool 2146 by being looped through spool 2146, in accordance with someapplications of the present invention. Spool 2146 is shaped to defineone or more holes 42 (e.g., two holes 42 a and 42 b, as shown)configured for looping a portion of contracting member 30 therethrough,as described hereinbelow. In such an application:

(a) a middle portion, which defines a first end portion 1230, ofcontracting member 30 is coupled to spool 2146 by being looped throughone or more holes 42,

(b) first and second portions that extend (1) through coupling member 35of housing 1042, from the first end portion looped through spool 2146(2) through coupling member 31 of housing 1042, and (3) toward a secondend 23 of structure 22, and

(c) first and second free ends (and respective portions of contractingmember 30) are coupled to second end 23 of structure 122 and define asecond end portion 1232 of contracting member 30.

Reference is now made to FIGS. 5 and 29. It is to be noted thatcontracting member 30 of structure 122, for some applications, isdisposed with respect to structure 122 in a manner as shown in FIG. 29.

Reference is now made to FIGS. 1 and 29. It is to be noted thatcontracting member 30 of annuloplasty structure 22, for someapplications, is disposed with respect to annuloplasty structure 22 in amanner as shown in FIG. 29, with the exception that second end portion1232 is coupled to second end 23 of structure 22 by being coupled to (1)a portion of the compressible element of body portion 24, or (2) to aportion of suture fastener 37. That is second end portion 1232 is notcoupled spool 46 or to a portion of the housing surrounding spool 46.

FIGS. 30A-B show a multilumen guide tube 300 coupled at a distal endthereof to adjusting mechanism 40 coupled to an annuloplasty structure3020, in accordance with some applications of the present invention.Annuloplasty structure comprises any annuloplasty structure as describedhereinabove, with specific reference to FIGS. 1-3, 5, 13, and 15. Forsome applications, the housing of adjusting mechanism 40 is coupled toone or more guide wires (e.g., two guide wires 160 and 162, as shown).It is to be noted that tube 300 may be directly coupled to adjustingmechanism 40, independently of guide wires. Following the implantationof the annuloplasty structures described herein, guide tube 300 isadvanced toward the implantation site along guide wires 160 and 162. Asshown in section A-A, guide tube 300 defines a primary lumen 302 andrespective secondary lumens 304 which surround guide wires 160 and 162.Guide tube 300 is advanced along guide wires 160 and 162 through anopening 330 in the heart, and ultimately toward adjusting mechanism 40.A distal end of guide tube 300 is coupled to the housing of adjustingmechanism 40, and a proximal end of guide tube 300 is coupled to aportion of subcutaneous tissue of the patient. A port 320 is coupled toa proximal end of guide tube 300 and is implanted subcutaneously beneathskin 310 of the patient.

For some applications, as shown in a system 3000 in FIG. 30A, tube 300extends from adjusting mechanism 40 at the annulus, through theinter-atrial septum (e.g., through the fossa ovalis), through the rightatrium. Tube then extends through the inferior vena cava, and throughthe femoral vein (not shown for clarity of illustration). In such anapplication, port 320 comprises a transfemoral port. FIG. 30B shows asystem 3100 in which tube 300 exits the heart through opening 330 andtoward a vicinity of the ribcage by way of illustration and notlimitation. In either application, port 320 projects slightly under skin310 to create a bump 312 (FIG. 30B).

Reference is made to FIGS. 9-11, 12A-B, 13, 14A-C, 15, 16A-C, and17-30A-B. It is to be noted that although structure 22 is shown as beingimplanted along annulus 92, structure 122 (as described hereinabove withreference to FIGS. 5, 6A-B, 7, and 8A-B) and structure 1122 (asdescribed hereinabove with reference to FIG. 15) may be implanted alongannulus 92 in a similar manner. Since structure 122 does not comprisesuture fasteners 41 and 37, sutures are threaded through braided sheath26 of structure 122 at respective locations along the “D”-shaped ring.As described hereinabove, structure 122 is placed along annulus 92 suchthat portions 49 of structure 122 are disposed between the trigones ofthe heart.

For applications in which structure 122 is transcatheterally advancedtoward annulus 92, structure 122 may be folded, or otherwise collapsed,such that it fits within the lumen of the advancement catheter.

Reference is again made to FIGS. 9-11, 12A-B, 13, 14A-C, 15, 16A-C, and17-30A-B. It is to be noted that for applications in which structures 22and 122 are implanted during an open-heart or minimally-invasiveprocedure, an incision is made in the heart, and a plurality of suturesare sutured along the annulus are used to facilitate advancement of theannuloplasty structure toward the annulus. Prior to advancement of theannuloplasty structure, portions of the plurality of sutures arethreaded through respective portions of the annuloplasty structure. Atool which delivers and facilitates contraction of the annuloplastystructure is coupled to the annuloplasty structure and advances theannuloplasty structure toward the annulus. Once the annuloplastystructure is positioned along the annulus and anchored thereto, theincision is closed around the tool using a purse string stitch. Thesubject is removed from the cardiopulmonary bypass pump and the heart isallowed to resume its normal function. While the heart is beating, theannuloplasty structure is then contracted, as described hereinabove, andresponsively, the annulus is contracted.

Reference is yet again made to FIGS. 9-11, 12A-B, 13, 14A-C, 15, 16A-C,and 17-30A-B. It is to be noted that the annuloplasty structure may beadvanced toward the annulus using any suitable delivery tool. Followingthe positioning of the annuloplasty structure along the annulus, thedelivery tool is disengaged from the annuloplasty structure. Then, tools70 or 2022 may be advanced toward housings 44, 144, or 1042 and engagespools 46, 246, or 2146. In some applications of the present invention,tools 70 or 2022 are advanced toward the annuloplasty structure along asuture coupled to the annuloplasty structure at one end and accessibleoutside the body of the subject and another end.

It is to be noted that for applications in which structures 22, 122, and1122, and device 1260 are implanted during an open-heart orminimally-invasive procedure, structures 22, 122, and 1122 and device1260 may be provided independently or in combination with sutures 130.

Reference is now made to FIGS. 1-30A-B. It is to be noted that thecontraction of structures 22, 122, and 1122 and device 1260 describedherein is reversible. That is, rotating spool 46 in a rotationaldirection that opposes the rotational direction used to contract theannuloplasty structure, unwinds a portion of flexible contracting member30 from around spools 46 or 2146. Unwinding the portion of flexiblecontracting member 30 from around spool 46 or 2146 thus feeds theportion of flexible contracting member 30 back into the lumen of bodyportion 24 of structures 22, 122, and 122 and device 1260, therebyslackening the remaining portion of flexible contracting member 30 thatis disposed within the lumen of body portion 24. Responsively, theannuloplasty structure gradually relaxes (i.e., with respect to itscontracted state prior to the unwinding) as the compressible element ofbody portion 24 gradually expands.

Reference is again made to FIGS. 1-30A-B. Typically, flexible member 30comprises a rope or cable that is constructed by coupling (e.g.,twisting, braiding, or otherwise coupling) a plurality of strands ofmetal, polymer, or fabric. This coupling of the strands enables member30 to conform to the external surface of the spool while not beingstructurally deformed by the winding of member 30 around the spool. Theannuloplasty structures described herein are flexible. That is, when ina contracted state of the structures described herein, contractingmember 30 does not have a tendency to expand radially or annularly.Additionally, the braided mesh surrounding the compressible elements ofbody portion 24 of the annuloplasty devices described herein keeps theentire device from expanding once the device has been contracted. Themesh provides a controlled regulation of the tendency to expand of thecompressible elements of the body portion of the annuloplasty devices.

Reference is again made to FIGS. 1-30A-B. It is to be noted thatstructures 22, 122, and 1122 and device 1260 may be stapled to theannulus using techniques known in the art.

Reference is yet again made to FIGS. 1-30A-B. It is to be noted thatfollowing initial contraction of annuloplasty structures 22, 122, and1122 and device 1260, structures 22, 122, and 1122 and device 1260 maybe further contracted or relaxed at a later state following the initialimplantation thereof. Using real-time monitoring, tactile feedback andoptionally in combination with fluoroscopic imaging, tools 70, 170, and2022 used to contract or relax annuloplasty structures 22, 122, and 1122and device 1260 may be reintroduced within the heart and engage spools46, 246, or 2146.

Reference is yet again made to FIGS. 1-30A-B. It is to be noted thatflexible contracting member 30 may be disposed outside the lumen definedby structures 22, 122, and 1122, and device 1260. For example, flexiblecontracting member 30 may be disposed alongside an outer wall ofstructures 22, 122, and 1122 and device 1260. In such applications ofthe present invention, structures 22, 122, and 1122 and device 1260 maynot be shaped to define tubular structures having respective lumensthereof, but rather be shaped as bands or ribbons which are not shapedto define a lumen.

It is to be noted that systems 20, 120, 1140, 2020, 2400, 2450, 2500,and assembly 900 for repairing a dilated annulus of the subject may beused to treat a valve of the subject, e.g., the tricuspid valve. It isto be still further noted that systems described herein for treatment ofvalves may be used to treat other annular muscles within the body of thepatient. For example, the systems described herein may be used in orderto treat a sphincter muscle within a stomach of the subject.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section and Cross-references section of thepresent patent application.

Additionally, the scope of the present invention includes applicationsdescribed in one or more of the following:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   U.S. Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;    -   U.S. Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed on Feb. 16,        2007;    -   U.S. Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   PCT Patent Application PCT/IL07/001503 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as WO 08/068756;    -   U.S. patent application Ser. No. 11/950,930 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as US Patent Application Publication        2008/0262609;    -   U.S. Provisional Patent Application 61/132,295 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed on Jun. 16, 2008;    -   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed on Dec. 22, 2008, which issued as U.S. Pat. No. 8,241,351;    -   U.S. Provisional Patent Application 61/207,908 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed on Feb. 17, 2009;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which issued as U.S. Pat. No.        8,147,542;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which issued as U.S. Pat. No. 8,715,342;    -   PCT Patent Application PCT/IL2009/000593 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed on Jun. 15, 2009, which published as WO        10/004546;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Aug. 27, 2009, which issued as U.S. Pat. No. 8,808,368;    -   U.S. Provisional Patent Application 61/283,445 to Sheps et al.,        entitled, “Delivery tool for rotation of spool and adjustment of        annuloplasty device,” filed Dec. 2, 2009; and/or    -   U.S. Provisional Patent Application 61/265,936 to Miller et al.,        entitled, “Delivery tool for implantation of spool assembly        coupled to a helical anchor,” filed Dec. 2, 2009.

All of these applications are incorporated herein by reference.Techniques described herein can be practiced in combination withtechniques described in one or more of these applications.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1-68. (canceled)
 69. A method, comprising: delivering into a heart of a patient an annuloplasty ring structure including a body portion and an adjusting mechanism configured to adjust a size of the body portion of the annuloplasty ring structure, the adjusting mechanism including a housing; and following the delivering, moving the housing with respect to the body portion.
 70. The method according to claim 69, wherein moving the housing with respect to the body portion comprises moving the housing with respect to the body portion while the body portion remains stationary.
 71. The method according to claim 69, further comprising removably coupling the adjusting mechanism of the annuloplasty ring structure to a tool, and wherein the method further comprises adjusting a dimension of annuloplasty ring structure by actuating the adjusting mechanism using the tool.
 72. The method according to claim 69, wherein moving the housing comprises swiveling the housing.
 73. The method according to claim 69, wherein: the body portion of the annuloplasty ring structure is flexible and is shaped so as to define a lumen therethrough, the annuloplasty ring structure includes a coupling attached to the housing and to the body portion, and configured to couple the housing to the body portion, and moving the housing comprises moving the housing using the coupling.
 74. The method according to claim 69, wherein delivering the annuloplasty ring structure comprises transcatheterally advancing the annuloplasty ring structure into an atrium of the heart.
 75. The method according to claim 69, wherein the annuloplasty ring structure includes a full annuloplasty ring structure.
 76. The method according to claim 69, wherein the annuloplasty ring structure includes a partial annuloplasty ring structure.
 77. The method according to claim 69, wherein the adjusting mechanism is coupled to one or more guide wires.
 78. The method according to claim 69, wherein the annuloplasty ring structure includes a contracting member coupled to the adjusting mechanism and extending along the body portion.
 79. The method according to claim 78, wherein: the annuloplasty ring structure is compressible along a longitudinal axis of the annuloplasty ring structure, the annuloplasty ring structure comprises a coiled structure having a lumen, and the contracting member is disposed within the lumen of the coiled structure, and the method further comprises, using the adjusting member, contracting the annuloplasty ring structure along the longitudinal axis by advancing portions of the contracting member toward the housing.
 80. The method according to claim 69, further comprising coupling the annuloplasty ring structure to tissue of an annulus of the heart of the patient, and following the coupling, adjusting a dimension of the annulus by adjusting a dimension of the annuloplasty ring structure using the adjusting mechanism.
 81. The method according to claim 80, wherein adjusting comprises bidirectionally rotating a rotatable structure of the adjusting mechanism.
 82. The method according to claim 81, wherein adjusting comprises coupling a delivery tool to a rotatable structure of the adjusting mechanism by rotating a rotatable knob of the delivery tool and screwing a screwdriver head of the delivery tool to a proximal portion the rotatable structure without rotating the rotatable structure, the rotatable structure having a first end shaped to define a first opening, and a second end shaped to define a second opening and having a lower surface thereof, the rotatable structure being shaped to define a channel extending from the first opening to the second opening, and at least one first coupling at the lower surface of the second end thereof, subsequently to the coupling, disengaging a second coupling from within the at least one first coupling of the rotatable structure by: pushing distally the rotatable knob, pushing distally a distal end of an elongate tool through the channel of the rotatable structure and beyond the second opening of the rotatable structure, responsively to the pushing distally of the distal end of the elongate tool, moving a depressible portion that is coupled to the second coupling and disposed in communication with the second opening of the lower surface of the rotatable structure; and subsequently to the disengaging, rotating the rotatable structure by rotating at least a portion of the delivery tool.
 83. Apparatus, comprising an annuloplasty ring structure configured to be implanted in a body of a subject, the annuloplasty ring structure comprising: a flexible body portion having a lumen therethrough; an adjusting mechanism configured to adjust a size of the body portion of the annuloplasty ring structure, the adjusting mechanism comprising a housing; and a coupling attached to the housing and to the body portion, and configured to couple the housing to the body portion in a manner in which the housing is moveable with respect to the body portion.
 84. The apparatus according to claim 83, wherein the coupling is configured to couple the housing to the body portion in a manner in which the housing is moveable with respect to the body portion while the body portion remains stationary.
 85. The apparatus according to claim 83, wherein the annuloplasty ring structure comprises a contracting member coupled to the adjusting mechanism and extending along the body portion.
 86. The apparatus according to claim 83, wherein the adjusting mechanism comprises a rotatable structure surrounded by the housing.
 87. The apparatus according to claim 83, wherein the coupling comprises a swivel coupling, and wherein the swivel coupling is configured to couple the housing to the body portion in a manner in which the housing swivels with respect to the body portion.
 88. The apparatus according to claim 87, wherein the housing comprises at least one coupling member, and wherein the swivel coupling comprises at least one swivel snap which is coupled to the at least one coupling member of the housing to couple a first portion of the body portion to the adjusting mechanism. 